Identity
- Trade Name
- ECHELON ENDOPATH EUDAMEDECHELON; ENDOPATH FDA UDI
- Generic Name
- Surgical staple loading unit, non-cutting FDA UDI
- Device Name
- Endoscopic Linear Cutter Reloads Green 4.1 mm, 6 rows FDA UDI
- Model / Reference
- ECR60G EUDAMEDFDA UDI
- Description
- Endoscopic Linear Cutter Reloads Green 4.1 mm, 6 rows FDA UDI
Identifiers
- Catalog Number
- ECR60G FDA UDI
- Primary DI / UDI-DI
- D-USMF000013107000048MP EUDAMED10705036001782 FDA UDI
- Basic UDI-DI
- B-USMF000013107000048MP EUDAMED
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H02030106 LINEAR STAPLER CARTRIDGES FOR VIDEOSURGERY EUDAMED
- GMDN Term
- Surgical staple loading unit, non-cutting FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- 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
CMR Substance
No
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 Endopath by Ethicon Endo-Surgery, LLC — Class III — 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-USMF000013107000048MP | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | 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 39c37efb-07e6-43db-a2e4-db5f68ae7c3e 61 fields · synced Jul 27, 2026
- FDA UDI 17c52f51-7994-4859-84ef-8bff4067c1fc 35 fields · synced May 30, 2026