Identity
- Trade Name
- ECHELON CONTOUR EUDAMEDECHELON FDA UDI
- Generic Name
- Surgical staple loading unit, non-cutting FDA UDI
- Device Name
- ECHELON CONTOUR Curved Cutter Reload EUDAMEDECHELON CONTOUR GST RELOAD BLUE FDA UDI
- Model / Reference
- GCR40B EUDAMEDFDA UDI
- Description
- ECHELON CONTOUR GST RELOAD BLUE FDA UDI
Identifiers
- Catalog Number
- GCR40B FDA UDI
- Primary DI / UDI-DI
- 10705036027461 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a0008272 EUDAMED
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H02020302 SINGLE PATIENT STRAIGHT SEMICIRCULAR STAPLER CARTRIDGES 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 | 0705036a0008272 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED e2f8861f-c18d-4c93-998d-1245d56fe383 61 fields · synced Jun 9, 2026
- FDA UDI 2e274004-f0ac-496a-b4af-c131411a87f7 36 fields · synced May 30, 2026