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g-Cath™ EZ delivery catheter with Snowshoe® suture anchors
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 208100
by USGI Medical
Identity
- Trade Name
- g-Cath™ EZ delivery catheter with Snowshoe® suture anchors EUDAMEDg-Cath Suture Anchor Delivery Catheter FDA UDI
- Generic Name
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
- Device Name
- g-Cath™ EZ delivery catheter with Snowshoe® suture anchors EUDAMEDg-Cath Suture Anchor Delivery Catheter FDA UDI
- Model / Reference
- 208100 EUDAMEDg-Cath EZ FDA UDI
- Description
- g-Cath Suture Anchor Delivery Catheter FDA UDI
Identifiers
- Catalog Number
- 208100 FDA UDI
- Primary DI / UDI-DI
- 10860009064710 EUDAMED00860009064713 FDA UDI
- Basic UDI-DI
- B-10860009064710 EUDAMED
- 510(k) Number
- K102916 FDA UDI
- FDA Product Code
- GAT FDA UDIGDW FDA UDIHET FDA UDI
- EMDN Code
- H010201020202 POLYESTER MULTIFILAMENT WITH NEEDLE FOR VIDEO SURGERY EUDAMED
- GMDN Term
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5000 FDA UDI878.4750 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
Yes
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-Cath™ EZ delivery catheter with Snowshoe® suture anchors by USGI Medical — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-10860009064710 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 f0ae43a7-301e-402b-bfab-c825009d68cd 61 fields · synced Jun 18, 2026
- FDA UDI c18e86da-f58c-4af8-aed2-b5de7e689712 35 fields · synced May 30, 2026