Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005809810

FEI Number

3005809810

Entity Name

Jarit GmbH

City/State/Country

Rietheim-Weilheim Baden-Wurttemberg, DE

Establishment Address

Langes Gewand 9, Rietheim-Weilheim Baden-Wurttemberg 78604, DE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Integra LifeSciences Corporation (Owner Number: 9004007)

Owner / Operator Contact Address

1100 Campus Rd, Princeton, NJ 08540, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K931959

PMA Number

N/A

All Registered Proprietary Names

Miltex Padgett CARB-BITE Jarit Integra Miltex Integra Miltex MicroFrance Padgett Integra Integra Jarit Padgett MicroFrance Miltex Integra Jarit Integra Miltex MicroFrance Jarit Miltex Integra MicroFrance Jarit Miltex Integra Jarit Miltex Miltex Jarit Integra Integra Miltex MicroFrance Jarit Redmond Integra Padgett Miltex Jarit Integra MicroFrance Jarit Integra Miltex MicroFrance Integra MicroFrance Ruggles-Redmond METIS Padgett MicroFrance Integra Jarit Miltex Integra Miltex Integra Jarit Miltex Jarit Integra MicroFrance Jarit Miltex Padgett Integra MicroFrance Padgett Jarit Miltex T Electron Petit-Point Jarit Integra GENERAL INSTRUMENT Padgett Miltex Integra Integra Jarit Integra Miltex Miltex Integra Miltex Jarit MicroFrance Integra Jarit Miltex Padgett Miltex Integra Jarit Integra Miltex MicroFrance Jarit Jarit Integra MicroFrance Integra MicroFrance Integra Jarit Padgett MicroFrance Miltex Integra Jarit Miltex Integra Jarit Integra Miltex Padgett Jarit MicroFrance CARB-BITE Miltex Integra Miltex Miltex MicroFrance Jarit Integra Miltex Integra Integra MicroFrance Padgett Jarit Ceram-A-Grip Miltex Petit-Point MicroFrance Jarit Padgett CARB-BITE Integra Integra MicroFrance Miltex Padgett Jarit MicroFrance Miltex Integra Padgett Integra Miltex MicroFrance Jarit Miltex Jarit Integra Integra Miltex Integra Jarit Probe 8" Miltex Jarit Jarit Miltex Miltex Jarit Integra Jarit Integra Miltex Jarit Miltex Carb-N-Sert Miltex Jarit Jarit Supercut Padgett CARB-EDGE MicroFrance Jarit Miltex Integra Jarit Integra Integra Jarit Miltex Ruggles-Redmond Jarit Integra Miltex Jarit Integra Jarit Integra Integra Ruggles-Redmond Integra Miltex Ruggles-Redmond Integra Padgett Integra Miltex Integra Jarit Ruggles-Redmond Integra Jarit Miltex Integra Allograft Wedge Impactor Instrument Integra Miltex Jarit Miltex Jarit MicroFrance Integra Miltex Jarit Miltex Miltex Integra Jarit Jarit Miltex Integra Jarit Integra Miltex Miltex Jarit Jarit Padgett MicroFrance Ruggles-Redmond Integra Miltex MicroFrance Jarit Integra Integra Jarit Ruggles-Redmond Codman Ventricular Needles Subcutaneous Guidewire Arkis Subcutaneous Guideware Integra Jarit Jarit Integra Miltex MicroFrance Integra Jarit Ruggles-Redmond Miltex Integra MicroFrance Miltex Jarit Integra Integra Ruggles-Redmond MicroFrance Padgett Miltex Jarit Miltex Integra Cardio-Grip Miltex Jarit Miltex Integra Miltex Integra MicroFrance Jarit Integra Jarit Miltex Integra Jarit Jarit Miltex Padgett Thompson MicroFrance Padgett Jarit Miltex Integra Miltex Integra MicroFrance MicroFrance Integra Jarit Padgett Integra Jarit MicroFrance Jarit Miltex Integra Jarit Integra MicroFrance Padgett Miltex 225520; 225525; P4480; P4835; P710; PM-4480; PM-4835; PM-710 Miltex Ruggles-Redmond Padgett MicroFrance Integra Jarit Jarit Integra MicroFrance Miltex Miltex Jarit Padgett Integra Miltex Jarit Jarit Miltex MicroFrance Integra MicroFrance Integra Miltex Jarit Supercut Jarit MicroFrance Ruggles-Redmond Padgett Miltex Integra Integra MicroFrance Jarit Miltex Padgett Jarit Miltex Integra RMH Integrator Tactile Tone Silitone Miltex GripLite Jarit Miltex Jarit Miltex Miltex Padgett Jarit Jarit Miltex MicroFrance Padgett Jarit Ruggles-Redmond Miltex Integra Jarit Integra MicroFrance Jarit Miltex Jarit Miltex Jarit Integra Miltex Padgett MicroFrance Jarit Padgett MicroFrance Miltex Ruggles-Redmond Integra Integra Miltex Miltex Jarit Integra Jarit Integra MicroFrance Integra MicroFrance Jarit Jarit Integra Miltex Miltex Jarit Jarit LumbarTrak Ruggles-Redmond Miltex Miltex Jarit MicroFrance Integra Carb-N-Sert Ruggles-Redmond Jarit Supercut Miltex Jarit MicroFrance Integra Integra Jarit Miltex MicroFrance Integra Miltex Integra Jarit Ruggles-Red Padgett Jarit Star Integra Petit-Pt Jarit Super CARB-BITE Miltex Jarit CARDIO-GRIP CARB-EDGE Jarit Miltex Integra Integra Cranial Access Kit Jarit Padgett Miltex Jarit Miltex Integra Integra Miltex Integra Jarit Miltex Jarit Jarit Miltex Integra Miltex Integra MicroFrance Jarit Jarit Miltex Integra Jarit Miltex Padgett MicroFrance Jarit Miltex Codman Instrument Tray Integra Integra Allograft Wedge Instrument Tray Assembly MicroFrance Integra Miltex Jarit Padgett Petit-Point MicroFrance Integra Integra Luxtec MLX 300 Watt Xenon Light Jarit Integra Ruggles-Redmond Miltex Integra Miltex Integra Miltex Ruggles-Redmond Miltex Jarit Padgett MicroFrance Integra Mayfield Base Unit Miltex Jarit Padgett Integra Miltex MicroFrance Integra Jarit Integra MicroFrance Integra Miltex Jarit Integra Miltex MicroFrance Integra Padgett Miltex Jarit MicroFrance Integra CARB-BITE Jarit Ruggles-Redmond Integra Anti-Rotation Peg Holder Integra Allograft Wedge Sizer Instrument Integra Allograft Wedge Instrument Set Jarit Miltex Integra MicroFrance Padgett Jarit Miltex Miltex Padgett Jarit Integra Jarit Padgett CARDIO-GRIP Miltex Ruggles-Redmond Integra Miltex Jarit Integra Miltex Jarit MicroFrance Integra Miltex Jarit MicroFrance Miltex Integra Jarit Miltex Jarit Padgett Jarit Miltex Integra MicroFrance Padgett Integra Ruggles-Redmond MicroFrance Jarit Miltex Miltex MicroFrance Integra Jarit Jarit Integra MicroFrance Jarit Miltex Integra Jarit MicroFrance Miltex Integra Jarit Miltex Integra Integra Padgett Jarit Jarit Supercut MicroFrance Miltex Carb-N-Sert CARB-EDGE 5-700;5-702;5801;5803;5804 Padgett Miltex Integra Jarit MicroFrance 33-52;33-53;33-54;33-55;33-57 Padgett Ceram-A-Grip Jarit Grip Deep Miltex Xcision Thompson Integra Tactile Tone Miltex Jarit Padgett MicroFrance Miltex Jarit Integra Integra Miltex Jarit Padgett Integra MicroFrance Jarit Miltex Integra Jarit Miltex MicroFrance Integra MicroFrance Integra MicroFrance Integra Padgett Miltex Jarit Ruggles-Redmond Padgett Integra Blade P4596 MicroFrance Integra Jarit Integra Jarit Miltex Integra Padgett Miltex Integra Jarit Padgett Miltex MicroFrance Integra MicroFrance Padgett Integra Miltex Integra Jarit Miltex Miltex Jarit Miltex Integra Jarit Integra Ruggles-Redmond Miltex Padgett MicroFrance Wound Measuring Kit Miltex Integra Jarit Miltex Padgett Jarit Integra Integra Ruggles-Redmond Miltex Jarit MicroFrance Integra Jarit Integra Integra Miltex Jarit Ruggles-Redmond Padgett Miltex Integra MicroFrance Galea Elevator Arkis Galea Elevator Integra Integra Miltex Miltex Integra Jarit Miltex MicroFrance Jarit Padgett MicroFrance Miltex Integra Padgett Jarit Integra MicroFrance Miltex Wing-Grip CODMAN Disposable Tunneler for Subcutaneous Placement of Catheters Arkis Subcutaneous Guidewire Loop Canulator / Canulator Padgett Jarit Miltex Jarit Ruggles-Redmond Padgett Integra Miltex MicroFrance Miltex Integra Jarit Jarit MicroFrance Jarit Integra Padgett Miltex MicroFrance Jarit Integra Ruggles-Redmond Integra Jarit Miltex Ruggles-Redmond Integra MicroFrance Miltex Padgett Jarit Integra Padgett Miltex MicroFrance Jarit Integra Jarit Integra

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	1981-04-24
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2006-03-20
NNR	Block, Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2004-10-05
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	2004-11-09
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2013-02-05
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	1999-05-19
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	1981-04-24
KAZ	Rasp, Frontal-Sinus	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	1981-04-24
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	1981-04-24
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2009-11-13
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2001-11-27
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2014-11-04
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
JYK	Holder, Ear Speculum	General, Plastic Surgery	Class 1	878.1800	1999-06-01
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2006-11-27
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
HER	Pelvimeter, External	Obstetrics/Gynecology	Class 1	884.4520	1981-04-24
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2007-05-29
GEO	File, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-04-24
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2003-09-09
FFR	Device, Locking, For Intestinal Clamp	Gastroenterology, Urology	Class 1	876.4730	2009-11-13
EIS	Remover, Crown	Dental	Class 1	872.4565	1981-04-24
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	1981-04-24
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	1981-04-24
NNU	Scissors, Wire Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2015-02-04
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	1981-04-24
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
GWZ	Percussor	Neurology	Class 1	882.1700	2013-04-22
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2015-03-30
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2009-11-19
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2003-08-05
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2009-05-27
BWB	Forceps, Tube Introduction	Anesthesiology	Class 1	868.5780	2003-08-05
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-04-24
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	1981-04-24
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-03-26
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	1992-08-26
HWQ	Passer	Orthopedic	Class 1	888.4540	2007-06-27
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2003-09-09
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2003-09-04
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	1981-04-24
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2003-09-04
HDK	Scissors, Episiotomy	Obstetrics/Gynecology	Class 1	884.4520	1981-04-24
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2005-03-02
FNS	Ring Cutter	General Hospital	Class 1	880.6200	1981-04-24
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	1981-04-24
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2003-09-09
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2003-08-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-11-19
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2015-05-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-08-07
GWY	Pinwheel	Neurology	Class 1	882.1750	1981-04-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-01-11
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2001-04-26
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2001-12-04
HBD	Handpiece (Brace), Drill	Neurology	Class 1	882.4325	2001-05-31
HWA	Impactor	Orthopedic	Class 1	888.4540	2001-04-26
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2001-12-04
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	1981-04-24
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-04-24
HDC	Tenaculum, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2009-01-20
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2014-12-01
HDM	Packer, Uterine	Obstetrics/Gynecology	Class 1	884.4520	1981-04-24
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	1981-04-24
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	1981-04-24
JYM	Inserter, Myringotomy Tube	Ear, Nose, Throat	Class 1	874.4420	2014-11-04
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	1999-04-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-06-04
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2003-08-05
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	1998-08-24
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-07-07
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	1981-04-24
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2000-12-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-02-25
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2014-04-15
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2001-12-04
JYF	Clamp, Ossicle Holding	Ear, Nose, Throat	Class 1	874.4420	2014-11-04
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	2006-08-03
MZY	Graft, Vascular, Stainless Steel Tunneler	Cardiovascular	Class 2	870.3450	2013-03-18
KQW	Goniometer, Nonpowered	Orthopedic	Class 1	888.1520	2006-10-05
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	1999-06-09
EJL	Bur, Dental	Dental	Class 1	872.3240	2001-12-04
JYW	Press, Vein	Ear, Nose, Throat	Class 1	874.4420	2004-06-07
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2007-05-29
FHI	Ring, Laparotomy	Gastroenterology, Urology	Class 1	876.4730	2015-02-04
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-12-14
HWT	Template	Orthopedic	Class 1	888.4800	2001-04-26
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1981-04-24
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2004-06-04
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2008-02-25
GWI	Discriminator, Two-Point	Neurology	Class 1	882.1200	2009-11-19
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	1981-04-24
KCC	Bistoury, Tracheal	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
KBR	Needle, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	2000-10-17
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	1999-05-05
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2000-10-24
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2001-08-09
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2008-03-26
HBO	Clip, Scalp	Neurology	Class 2	882.4150	2012-07-09
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	1981-04-24
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2008-03-26
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	1981-04-24
HTX	Rongeur	Orthopedic	Class 1	888.4540	1981-04-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-02-16
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2004-11-09
EXX	Probe, Rectal, Non-Powered	Gastroenterology, Urology	Class 1	876.4730	1981-04-24
GAI	Stripper, Vein, Reusable	General, Plastic Surgery	Class 1	878.4800	2009-11-19
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2003-08-05
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	1981-04-24
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	1981-04-24
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2001-08-06
DQR	Cannula, Catheter	Cardiovascular	Class 2	870.1300	2014-02-06
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	2014-11-04
JYE	Chisel, Middle-Ear	Ear, Nose, Throat	Class 1	874.4420	2009-11-19
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2001-11-27
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2003-07-24
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2009-11-19
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	1981-04-24
JYD	Chisel, Mastoid	General, Plastic Surgery	Class 1	878.4800	2003-08-04
KBQ	Knife, Tonsil	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2003-08-05
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1981-04-24
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	1981-04-24
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2006-02-22
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2003-08-05
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-12-14
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2003-08-05
EYR	Tourniquet, Gastro-Urology	General, Plastic Surgery	Class 1	878.5900	2004-06-04
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1981-04-24
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	1981-04-24
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1981-04-24
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2000-12-14
JYP	Knife, Myringotomy	Ear, Nose, Throat	Class 1	874.4420	2009-11-19
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2003-09-09
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2016-02-03
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2012-07-09
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2009-11-19
EMP	Marker, Periodontic	Dental	Class 1	872.4565	1981-04-24
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	1992-08-26
EJY	Pliers, Operative	Dental	Class 1	872.4565	1981-04-24
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2012-09-18
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2012-09-18
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2015-03-30
KTZ	Caliper	Orthopedic	Class 1	888.4150	1999-05-10
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
JZY	Knife, Laryngeal	Ear, Nose, Throat	Class 1	874.4420	2014-11-04
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	1981-04-24
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	1981-04-24
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	1981-04-24
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2005-03-24
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1981-04-24
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2015-03-30
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2004-11-09
HXB	Probe	Orthopedic	Class 1	888.4540	2003-09-04
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2012-07-18
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2013-02-26
HTP	File	Orthopedic	Class 1	888.4540	2003-09-04
KBH	Adenotome	Ear, Nose, Throat	Class 1	874.4420	1981-02-24
KBT	Punch, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2003-09-04
HWK	Trephine	Orthopedic	Class 1	888.4540	2005-03-23
HXR	Spatula, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2003-09-04
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2009-11-13
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2001-08-06
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
JYR	Nipper, Malleus	Ear, Nose, Throat	Class 1	874.4420	2007-01-18
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2015-02-25
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1981-04-24
JZD	Snare, Ear	Ear, Nose, Throat	Class 1	874.4420	2008-03-26
EKB	Explorer, Operative	Dental	Class 1	872.4565	1981-04-24
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-09-09
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2003-08-05
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	1981-04-24
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	1981-04-24
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-10-24
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	1981-04-24
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	2004-11-09
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	1981-04-24
JZA	Rongeur, Mastoid	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2015-03-28
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2007-06-27
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2018-04-18
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	1981-04-24
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	2004-04-12
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2003-08-05
HWJ	Awl	Orthopedic	Class 1	888.4540	2000-12-14
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	1981-04-24
HWO	Skid, Bone	Orthopedic	Class 1	888.4540	1981-04-24
FZR	Contractor, Surgical	General, Plastic Surgery	Class 1	878.4800	2000-12-14
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	1981-04-24
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2015-02-06
HXG	Tamp	Orthopedic	Class 1	888.4540	2004-06-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-06-28
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2003-09-04
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1981-04-24
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2003-09-04
KBE	Snare, Nasal	Ear, Nose, Throat	Class 1	874.4420	2003-09-04
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	1981-04-24
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2000-10-24
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-12-14
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1981-04-24
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2014-01-13
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2009-11-19
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2000-12-14
EMS	Curette, Periodontic	Dental	Class 1	872.4565	1981-04-24
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2001-04-26
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	1981-04-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-09-27

Official Correspondent

No official correspondent registered.

US Agent Details

Kerri DiPietro Business: INTEGRA LIFESCIENCES CORPORATION Email: kerri.dipietro@integralife.com Phone: (774) 7196909

Related Public Records

Same Entity

Integra LifeSciences Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015194982	SURGICAL INNOVATION ASSOCIATES, INC.	Chicago, IL, US
3013505638	REBOUND THERAPEUTICS, CORPORATION	Irvine, CA, US
3006697299	INTEGRA LIFESCIENCES (IRELAND) LIMITED	SRAGH TULLAMORE Offaly, IE
2648988	INTEGRA NEUROSCIENCES	ANASCO, PR, US
9680837	INTEGRA MICROFRANCE SAS	SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071458	Integra LifeSciences Corporation	MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS	2007-06-13
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K914226	E.I. Dupont DE Nemours & Co., Inc.	ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK	1991-11-19
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

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3014201171	KLS Martin Malaysia Sdn. Bhd.	Simpang Ampat Pulau Pinang, MY
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3007603855	KARDIUM Inc.	Burnaby British Columbia, CA
9611813	CHRISTIAN DIENER GMBH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005809810. Last updated year: 2026. Please use registration number 3005809810 when referencing this establishment in official correspondence.