Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005273623

FEI Number

3005273623

Entity Name

Heuer International (A division of GST Corporation Limited)

City/State/Country

NOIDA Uttar Pradesh, IN

Establishment Address

142 A/52, NOIDA SPECIAL ECONOMIC ZONE,, NOIDA PHASE-2, NOIDA Uttar Pradesh 201305, IN

Establishment Type(s)

Foreign Private Label Distributor,Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

GST CORPORATION LIMITED (Owner Number: 9075660)

Owner / Operator Contact Address

B-13 OKHLA INDUSTRIAL AREA,, PHASE-2, NEW DELHI, IN-DL 110020, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GSTC Gold Cross Heuer Heuer GSTC Gold Cross Heuer GSTC Gold Cross GSTC Heuer Gold Cross GSTC Heuer Gold Cross Heuer GSTC Gold Cross GSTC Gold Cross Heuer GSTC Gold Cross Heuer GSTC Gold Cross Heuer Gold Cross GSTC Heuer Heuer Gold Cross GSTC GSTC Gold Cross Heuer GSTC Gold Cross Heuer GSTC Gold Cross Heuer GSTC Heuer Gold Cross GSTC Gold Cross Heuer GSTC Gold Cross Heuer Heuer GSTC Gold Cross Heuer Gold Cross GSTC GSTC Gold Cross Heuer Heuer GSTC Gold Cross GSTC Heuer Gold Cross Heuer Gold Cross GSTC Heuer GSTC Gold Cross Gold Cross Heuer GSTC Gold Cross Heuer GSTC GSTC Heuer Gold Cross Gold Cross Heuer GSTC Heuer GSTC Gold Cross Heuer GSTC GSTC Gold Cross Heuer Gold Cross Heuer GSTC HEUER Heuer GSTC Gold Cross GSTC Heuer Gold Cross GSTC Heuer Gold Cross Heuer GSTC Heuer GSTC Gold Cross Heuer GSTC Gold Cross Heuer Gold Cross GSTC Gold Cross GSTC Heuer Gold Cross GSTC Heuer GSTC Gold Cross Heuer Heuer GSTC Gold Cross Gold Cross GSTC Heuer GSTC Heuer GSTC Heuer Gold Cross Gold Cross Heuer GSTC Heuer Gold Cross GSTC Heuer GSTC Gold Cross GSTC Gold Cross Heuer Heuer Gold Cross GSTC GSTC Heuer Gold Cross Gold Cross GSTC Heuer Gold Cross Heuer GSTC Heuer GSTC Gold Cross Gold Cross Heuer GSTC Heuer GSTC Gold Cross Gold Cross Heuer GSTC Gold Cross Heuer GSTC Heuer GSTC Gold Cross Heuer GSTC Gold Cross Heuer Gold Cross GSTC GSTC Heuer Gold Cross Heuer Gold Cross GSTC GSTC Gold Cross Heuer GSTC Gold Cross Heuer Heuer GSTC Gold Cross GSTC Heuer Gold Cross Heuer Gold Cross GSTC GSTC Heuer Gold Cross Heuer GSTC Gold Cross Heuer GSTC Gold Cross Heuer GSTC Gold Cross Heuer GSTC Gold Cross Gold Cross GSTC Heuer Heuer GSTC Gold Cross Heuer Gold Cross GSTC GSTC Heuer Gold Cross Heuer Gold Cross GSTC Gold Cross Heuer Gold Cross GSTC Heuer Gold Cross Heuer GSTC GSTC Gold Cross Heuer Gold Cross Heuer GSTC Heuer Gold Cross GSTC GSTC Gold Cross Heuer GSTC Gold Cross Heuer Gold Cross Heuer GSTC GSTC Gold Cross Heuer Gold Cross Heuer GSTC Heuer Gold Cross GSTC Heuer GSTC Gold Cross GSTC Heuer Gold Cross GSTC Gold Cross Heuer Gold Cross Heuer GSTC Heuer GSTC Gold Cross GSTC Heuer Gold Cross Heuer GSTC GSTC Gold Cross Heuer Gold Cross GSTC Heuer Gold Cross Heuer GSTC Heuer GSTC Gold Cross Gold Cross Heuer GSTC Gold Cross GSTC Heuer GSTC Gold Cross Heuer GSTC Gold Cross Heuer Gold Cross GSTC Heuer Gold Cross GSTC Heuer Heuer GSTC Gold Cross GSTC Heuer Gold Cross Gold Cross GSTC Heuer Heuer Gold Cross GSTC Gold Cross Heuer GSTC Heuer GSTC Gold Cross Heuer GSTC Gold Cross Heuer GSTC Gold Cross Heuer GSTC Gold Cross Heuer GSTC Gold Cross Gold Cross GSTC Heuer GSTC Heuer Gold Cross Heuer GSTC Gold Cross Gold Cross GSTC Heuer GSTC Gold Cross Heuer GSTC Heuer Gold Cross Heuer GSTC Gold Cross Gold Cross Heuer GSTC GSTC Heuer Gold Cross Gold Cross Heuer GSTC Heuer Gold Cross GSTC Heuer Gold Cross Heuer Gold Cross GSTC Gold Cross Heuer GSTC Gold Cross Heuer GSTC GSTC Heuer Gold Cross Heuer GSTC GSTC Heuer Heuer Gold Cross GSTC Heuer Gold Cross GSTC Gold Cross GSTC Heuer Gold Cross Heuer GSTC Heuer GSTC Heuer Gold Cross GSTC GSTC Heuer GSTC Gold Cross Heuer Heuer GSTC Gold Cross GSTC Gold Cross Heuer Gold Cross Heuer GSTC Gold Cross GSTC Heuer GSTC Heuer Gold Cross Gold Cross GSTC Heuer Gold Cross GSTC Heuer GSTC Gold Cross Heuer Heuer GSTC Gold Cross Heuer Gold Cross GSTC GSTC Heuer Gold Cross Gold Cross Heuer GSTC Heuer Gold Cross GSTC GSTC Heuer Gold Cross Heuer Gold Cross GSTC Gold Cross Heuer GSTC Heuer Gold Cross GSTC Heuer GSTC Gold Cross Gold Cross GSTC Heuer GSTC Heuer Gold Cross Gold Cross GSTC Heuer GSTC Heuer Gold Cross GSTC Heuer Gold Cross Heuer GSTC GSTC Heuer Gold Cross GSTC Heuer Gold Cross GSTC Heuer Gold Cross Heuer Gold Cross GSTC Heuer GSTC Gold Cross Gold Cross Heuer GSTC Gold Cross Heuer GSTC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2019-03-22
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2019-03-22
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2019-03-22
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2019-03-22
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2013-02-07
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	2013-02-07
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2013-02-07
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2013-02-07
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-02-07
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2013-02-07
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2013-02-07
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2013-02-07
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2013-02-07
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2021-01-19
DZM	Needle, Dental	Dental	Class 1	872.4730	2019-03-22
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2019-03-22
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-02-07
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2020-01-09
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2020-01-09
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2013-02-07
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2013-02-07
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2019-03-22
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2019-03-22
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2007-08-08
BYW	Device, Rebreathing	Anesthesiology	Class 1	868.5675	2019-03-22
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2007-08-08
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2019-03-22
GHO	Hemocytometer	Hematology	Class 1	864.6160	2019-03-22
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2019-03-22
LXI	Guide, Drill, Ligament	General, Plastic Surgery	Class 1	878.4820	2021-01-19
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2019-03-22
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2019-03-22
HHI	System, Abortion, Vacuum	Obstetrics/Gynecology	Class 2	884.5070	2023-11-27
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2021-01-19
FSO	Microscope, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4700	2020-01-09
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2013-02-07
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2013-02-07
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2019-03-22
ISL	Joint, Hip, External Limb Component	Physical Medicine	Class 1	890.3420	2019-03-22
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-03-22
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2019-03-22
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2013-02-07
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2010-05-13
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2020-01-09
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2019-03-22
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2021-01-19
HGN	Stethoscope, Fetal	Obstetrics/Gynecology	Class 1	884.2900	2019-03-22
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2013-02-07
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2019-03-22
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2013-02-07
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2020-01-09
HXB	Probe	Orthopedic	Class 1	888.4540	2013-02-07
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2013-02-07
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2019-03-22
BYO	Bottle, Blow	Anesthesiology	Class 1	868.5220	2021-01-19
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2013-02-07
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2020-01-09
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2019-03-22
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	2019-03-22
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-02-07
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2019-03-22
GGY	Pipette, Diluting	Hematology	Class 1	864.6160	2019-03-22
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	2020-01-09
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2013-02-07
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-03-22
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2019-03-22
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-01-09
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2019-03-22
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-03-23
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-07
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2005-07-27
PMK	Cpr Aid Device Without Feedback	Cardiovascular	Class 1	870.5210	2019-03-22
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2019-03-22
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2013-02-07
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-03-22
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-02-07
EFN	Cotton, Roll	Dental	Class 1	872.6050	2020-01-09
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2020-01-09
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2013-02-07
DRC	Trocar	Cardiovascular	Class 2	870.1390	2020-01-09
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-02-07
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2013-02-07
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2019-03-22
KTZ	Caliper	Orthopedic	Class 1	888.4150	2013-02-07
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-02-07
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2019-03-22
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-02-07
HSQ	Belt, Pelvic, Traction	Orthopedic	Class 1	888.5890	2013-02-07
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2020-01-09
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2019-03-22
IRS	Head Halter, Traction	Physical Medicine	Class 1	890.5925	2013-02-07
GHK	Centrifuge, Microsedimentation	Hematology	Class 1	864.5350	2019-03-22
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2013-02-07
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2019-03-22
KMO	Binder, Elastic	General Hospital	Class 1	880.5160	2020-01-09
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2021-01-19
EXH	Bag, Urinary, Ileostomy	Gastroenterology, Urology	Class 1	876.5900	2020-01-09
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2021-01-19
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-03-22
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2013-02-07
JQY	Ph Meter	Clinical Chemistry	Class 1	862.2050	2020-01-09
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2013-02-07
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2019-03-22
CAL	Laryngoscope, Non-Rigid	Anesthesiology	Class 1	868.5530	2019-03-22
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2020-01-09
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2007-08-08
FKC	Clamp, Cannula	Gastroenterology, Urology	Class 1	876.5540	2020-01-09
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2013-02-07
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2013-02-07
IBK	Microscope, Fluorescence/U.V.	Pathology	Class 1	864.3600	2013-02-07
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2013-02-07
HAS	Needle, Neurosurgical Suture	Neurology	Class 1	882.4650	2013-02-07
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-01-09
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2007-06-01
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-02-07
ENW	Catheter, Nasopharyngeal	Ear, Nose, Throat	Class 1	874.4175	2020-01-09
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2007-06-01
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2007-08-08
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-02-07
JCY	Catheter, Infusion	General, Plastic Surgery	Class 1	878.4200	2019-03-22
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2020-01-09
HKF	Mirror, Headband, Ophthalmic	Ophthalmic	Class 1	886.1500	2007-08-08
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2007-12-15
HTQ	Broach	Orthopedic	Class 1	888.4540	2013-02-07
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2019-03-22
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2013-02-07
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2013-02-07
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2019-03-22
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2007-06-01
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2013-02-07
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2013-02-07
PMV	Orthosis, Limb, For Back Pain	Physical Medicine	Class 1	890.3475	2019-03-22
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2019-03-22
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2013-02-07
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2019-03-22
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2021-01-19
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2021-01-19
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2019-03-22
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2019-03-22
JQO	Balance, Analytical	Clinical Chemistry	Class 1	862.2050	2019-03-22
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2007-08-08
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2021-01-19
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2019-03-22
KCI	Trocar, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2021-01-19
ITC	Stirrup, External Brace Component	Physical Medicine	Class 1	890.3410	2019-03-22
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2007-08-08
EXJ	Device, Incontinence, Urosheath Type, Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-02-07
FFH	Collector, Urine, Pediatric, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2020-01-09
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2013-02-07
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-02-07
GWZ	Percussor	Neurology	Class 1	882.1700	2019-03-22
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2013-02-07
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2013-02-07
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2007-08-08
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2007-12-15
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2019-03-22
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2019-03-22
JPW	Pump, Nebulizer, Electrically Powered	Ear, Nose, Throat	Class 1	874.5220	2020-01-09
PCM	Portable Liquid Oxygen Unit Stand	Physical Medicine	Class 1	890.5050	2020-01-09
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	Class 1	866.2660	2019-03-22
EYR	Tourniquet, Gastro-Urology	General, Plastic Surgery	Class 1	878.5900	2019-03-22
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2011-07-19
ILZ	Accessories, Traction	Physical Medicine	Class 1	890.5925	2013-02-07
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	General Hospital	Class 1	880.5240	2019-03-22
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-01-09
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2019-03-22
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2019-03-22
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2020-01-09
KPH	Catheter, Rectal For Continent Ileostomy	Gastroenterology, Urology	Class 1	876.5030	2021-01-19
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-02-07
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2019-03-22
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2013-02-07
PWA	Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	Obstetrics/Gynecology	Class 1	884.5150	2020-01-09
FLK	Thermometer, Clinical Mercury	General Hospital	Class 2	880.2920	2019-03-22
KIL	Positioner, Socket	Orthopedic	Class 1	888.4540	2013-02-07
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2019-03-22

Official Correspondent

MANU GROVER

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

GST CORPORATION LIMITED

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05
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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005273623. Last updated year: 2026. Please use registration number 3005273623 when referencing this establishment in official correspondence.