Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807315

FEI Number

3002807315

Entity Name

SYNERGY HEALTH STERILISATION UK LTD

City/State/Country

Daventry Northamptonshire, GB

Establishment Address

Drayton Fields Industrial Estate, Brunel Close, Daventry Northamptonshire NN11 8RB, GB

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIS Corporation (Owner Number: 10042227)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Xiros8315 (DV) - Pitch Patch Tissue Reinforcement 30mm x 20mm. 102-1090, Pitch Patch Tissue Reinforcement 35mm x 25mm. Surgical_Inno3346 (DV) - YelloPort Elite Single Use Seal KeySurgical6941 (DV) - Electro Lube Summit8301 (DV) - HiVac7 Bone Cement Mixing and Delivery System (Triple application) C703 Summit8301 (DV) - HiVac7 with Femoral Cement Pressuriser CP701 Summit8301 (DV) - 9mm Nozzle with Nozzle Extruder Escoffier11264 (MC) - DISPENSER, CEMENT Zimmer (DV,RG) - Taperloc Complete Xiros8315 (DV) - CC-Hook BlinkMedical8355 (TH) - Hook, Surgical, General & Plastic Surgery Surgical_Inno3346 (DV,BF*) - LogiFlex Gastric Band Positioning Device Xiros8315 (DV) - 102-1101 Infinity-Lock 5 mm x 400 mm; 102-1102 Infinity-Lock 7 mm x 400 mm Xiros8315 (DV) -102-1082 Poly-Tape 20 mm x 800 mm; 102-1086 Poly-Tape 5 mm x 800 mm; 102-1087 Poly-Tape 7 mm x 800 mm Xiros8315 (DV) - 102-1005 Poly-Tape 5 mm x 500 mm; 102-1080 Poly-Tape 10 mm x 800 mm; 102-1081 Poly-Tape 15 mm x 800 mm; Xiros8315 (DV) - 10050 SIC Graft Xiros8315 (DV) - 102-1083 Poly-Tape 30 mm x 800 mm; 102-1143 AchilloCordPLUS DeSoutter8410 (DV) - Passing Pin DeSoutter8410 (DV,RG) - Stericut Summit (DV) - Medium Port MiniMix Bone Cement Mixing System SMMM1 Summit8301 (DV) - Mixing Bowl, Spatula B710 Summit8301(DV) - HiVac Bowl Bone Cement Mixing System B713 Zimmer (DV,RG,WP) - G7 OSSEOTI ACETUBLAR SHELLS Zimmer (RG,DV) - Taperloc Complete, Size 5 And 6 Xiros8315 (DV) - Poly-Tape (102-1086, 102-1087, 102-1080, 102-1081, 102-1082) Infinity Lock (102-1100, 102-1101, 102-110 Xiros8315 (DV) - Infinity-Lock Button System Summit8301 (DV) - Femoral Cement Pressuriser P721 KeySurgical6941 (DV) - Mr. Clear Zimmer (DV,RG) - Vanguard SSK 360 Revision Knee System Bedal12006 (ED,VL2) - Air S,M; Flex XS, Flex S, Bedal Flex M; Bedal PICC/CVC, PIVC, FlexGrip PICC, FlexGRIP Jr PIVC Bedal12006 (ED,VL2) - FlexGRIP Neo Alpha; FlexGRIP Neo First; FlexGRIP Neo PIVC Bedal12006 (ED,VL2) - NEX- Universal-CVC; 1 Drainpatch; 3 PIVC; 4 EPI/PNB, FlexGrip EPI/PNB; 5 Universal Bedal12006 (ED,VL2) -FlexGrip Universal; FlexGRIP Alpha, FlexGRIP Foley- Universal; FlexGrip CVC; FlexGRIP Jr. PICC 2.7 Xiros8315 (DV) - Infinity-Lock 3, Infinity-Lock 5 Molnlycke (KK,VL) - Lyofoam Max FirstWater14138 (RG) - DUP86266-9 - Xtrasorb Foam Adhesive Molnlycke (KK,VL) - Lyofoam Dressings FirstWater14138 (RG) - DUP86144-9 - Xtrasorb Foam Non- Adhesive FirstWater14138 (RG) - DUP86233-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86122-9 - Xtrasorb Foam Non- Adhesive AdvMed8429 (BF) - "McKesson Calcium Alginate Dressing FirstWater14138 (RG) - DUP86244-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86188-9 - Xtrasorb Foam Non- Adhesive Surgical_Inno3346 (DV) - YelloPort Elite Single Use Seal Xiros8315 (DV) - FlexPasser Tendon Retrieval Kit Xiros8315 (DV) - Poly-Tape, 30 mm x 800 mm (open weave). 102-1083 DeSoutter8410 (DV,RG) - Lavage pump kits. DeSoutter8410 (DV,RG) - Irriagtion Kits Xiros8315 (DV) - Rigid Probe (202-3023), Malleable Probe (202-3026) Zimmer (DV,RG) - G7 Finned Acetabular Shell Surgical_Inno3346 (DV,BF*) - YelloPort Plus Single Use Valves

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2025-06-26
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-02-02
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-04-25
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2017-12-20
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2020-12-08
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2023-02-03
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2023-08-14
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-08-14
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2017-12-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-11-20
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-03-26
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2020-12-08
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-11-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-06-16
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2012-12-20
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2013-03-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-11-28
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2013-01-17
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-03
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2013-01-03
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-01-03
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-01-03
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2013-01-03
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-01-03
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2013-01-03
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-01-03
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-01-03
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2013-01-03
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-01-03
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2013-01-03
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2013-12-06
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-02-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-12-19
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-06-18
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2013-01-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-11-02
MAF	Stent, Coronary	Unknown	Class 3	N/A	2012-12-20
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-12-20
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2012-12-20
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-12-20
NWX	Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring	Unknown	Class 3	N/A	2012-12-20
NIN	Stent, Renal	Unknown	Class 3	N/A	2012-12-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-03-19
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2013-01-21
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-17
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2023-01-17
QUW	Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament	General, Plastic Surgery	Class 2	878.3300	2023-01-17
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-12-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2015-08-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-08-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-08-11
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2015-08-11
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2015-08-11
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2015-08-11
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2015-08-11
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2015-08-11
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-02-28
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	Class 3	878.4490	2012-12-20
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)	Ear, Nose, Throat	Class 2	874.3620	2013-03-15
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-12-03
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-01-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-03-05
IYX	Camera, Scintillation (Gamma)	Radiology	Class 1	892.1100	2013-03-05
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2015-09-16
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2013-03-15
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2016-11-18
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-01-21
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2012-12-20
MTJ	Wax, Bone	Unknown	Class U	N/A	2019-03-07
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2013-03-15
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-12-03
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-12-29
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2014-12-29
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2014-12-29
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2014-12-29
PBI	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	Orthopedic	Class 2	888.3310	2014-12-29
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2014-12-29
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2014-12-29
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2014-12-29
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2013-12-13
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2013-12-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-12-13
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2013-12-13
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-12-13
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2015-08-26
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-01-03
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2013-01-03
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2013-01-03
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2013-01-03
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-01-03
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2013-01-03
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-01-03
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-01-03
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-01-03
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2013-01-03
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-01-03
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2018-07-11
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-10-31
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2022-10-31
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2022-12-24
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2019-05-17
OGS	Myringotomy Procedure Kit	Ear, Nose, Throat	Class 2	874.3880	2020-12-08
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2017-01-20
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-11-21
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2021-06-16
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2015-08-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-03
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-03
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2013-04-05
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2023-12-18
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2015-07-22
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-07-11
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-12-19
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2020-06-01
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2012-12-20
NHV	System, Water Purification, General Medical Use	Gastroenterology, Urology	Class 2	876.5665	2019-03-01
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-01-12
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2022-11-19
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-01-21
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2013-01-21
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2023-05-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-01-02
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-04-25
HWQ	Passer	Orthopedic	Class 1	888.4540	2019-10-10
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-12-05
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2023-08-17
HXB	Probe	Orthopedic	Class 1	888.4540	2020-11-30
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2015-01-09
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-01-09
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2015-01-09
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2015-01-09
PBI	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	Orthopedic	Class 2	888.3310	2015-01-09
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2015-01-09
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-01-09
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2015-01-09
NHV	System, Water Purification, General Medical Use	Gastroenterology, Urology	Class 2	876.5665	2020-01-28
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-03-26
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-04-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-01-16
KCW	Epilator, High Frequency, Needle-Type	General, Plastic Surgery	Class 1	878.5350	2013-03-22
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2020-11-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-03-19

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: Synergy Health Email: Becky_Aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

STERIS Corporation

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807315. Last updated year: 2026. Please use registration number 3002807315 when referencing this establishment in official correspondence.