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g-Lix Tissue Grasper
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 301010
by USGI Medical
Identity
- Trade Name
- g-Lix Tissue Grasper EUDAMEDg-Lix Tissue Grabber FDA UDI
- Generic Name
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
- Device Name
- g-Lix Tissue Grasper EUDAMEDg-Lix Tissue Grabber FDA UDI
- Model / Reference
- 301010 EUDAMEDg-Lix FDA UDI
- Description
- g-Lix Tissue Grabber FDA UDI
Identifiers
- Catalog Number
- 301010 FDA UDI
- Primary DI / UDI-DI
- 00860009064744 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00860009064744 EUDAMED
- 510(k) Number
- K061268 FDA UDI
- FDA Product Code
- HET 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 IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1720 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-Lix Tissue Grasper by USGI Medical — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061268 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00860009064744 | Class IIa | Active |
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Manufacturer
- Manufacturer
- USGI Medical
- EUDAMED SRN
- US-MF-000031970
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (3)
- EUDAMED b053e991-efb1-494d-9e88-b65861c36a34 61 fields · synced Jun 19, 2026
- FDA UDI 5bcd2496-401c-4979-859a-5b99b0baa16b 35 fields · synced May 29, 2026
- FDA 510(k) K061268 1 fields · synced May 18, 2026