Identity
- Trade Name
- g-Prox EZ-16 EUDAMEDg-Prox EZ Endoscopic Grasper FDA UDI
- Generic Name
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
- Device Name
- g-Prox EZ-16 EUDAMEDg-Prox EZ Endoscopic Grasper 16 FDA UDI
- Model / Reference
- 208200 EUDAMEDg-Prox EZ-16 FDA UDI
- Description
- g-Prox EZ Endoscopic Grasper 16 FDA UDI
Identifiers
- Catalog Number
- 208200 FDA UDI
- Primary DI / UDI-DI
- 00860009064720 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00860009064720 EUDAMED
- 510(k) Number
- K103688 FDA UDI
- FDA Product Code
- OCZ FDA UDIHET FDA UDI
- EMDN Code
- G03080199 GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI884.1720 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
g-Prox EZ-16 by USGI Medical — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00860009064720 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- USGI Medical
- EUDAMED SRN
- US-MF-000031970
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED 4b834668-b400-4e45-b74b-a328722afc9b 61 fields · synced Jun 17, 2026
- FDA UDI e8cff9fd-5268-4afb-ae84-1729ea538131 35 fields · synced May 30, 2026