Identity
- Trade Name
- ECHELON CONTOUR EUDAMEDECHELON FDA UDI
- Generic Name
- Surgical staple loading unit, non-cutting FDA UDI
- Device Name
- ECHELON CONTOUR Curved Cutter EUDAMEDECHELON CONTOUR W/ BLUE RELOAD FDA UDI
- Model / Reference
- GCS40B EUDAMEDFDA UDI
- Description
- ECHELON CONTOUR W/ BLUE RELOAD FDA UDI
Identifiers
- Catalog Number
- GCS40B FDA UDI
- Primary DI / UDI-DI
- 10705036027515 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000816Y EUDAMED
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H02020301 SINGLE PATIENT STRAIGHT SEMICIRCULAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMED
- GMDN Term
- Surgical staple loading unit, non-cutting FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Market of Registration
- Belgium 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
Sutures
Yes
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
MR Conditional FDA UDI
Echelon Contour by Ethicon Endo-Surgery, LLC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705036a000816Y | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED 202ca0e4-0272-4644-b4a6-5d848c1553f2 61 fields · synced Sep 17, 2026
- FDA UDI 549daf4b-0f6a-4df6-bc33-7881eb37313d 36 fields · synced May 30, 2026