Identity
- Trade Name
- ECHELON LINEAR EUDAMEDEchelon Linear Cutter FDA UDI
- Generic Name
- Open-surgery manual linear cutting stapler, single-use FDA UDI
- Device Name
- ECHELON LINEAR Cutter EUDAMEDEchelon Linear Cutter 60mm FDA UDI
- Model / Reference
- GLC60 EUDAMEDFDA UDI
- Description
- Echelon Linear Cutter 60mm FDA UDI
Identifiers
- Catalog Number
- GLC60 FDA UDI
- Primary DI / UDI-DI
- 10705036030874 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000897G EUDAMED
- 510(k) Number
- K223760 FDA UDI
- FDA Product Code
- GDW FDA UDIGAG FDA UDI
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMED
- GMDN Term
- Open-surgery manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4750 FDA UDI878.4740 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Open-surgery manual linear cutting stapler, single-use
Echelon Linear by Ethicon Endo-Surgery, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705036a000897G | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 a9e6522a-a25b-4453-959a-fa10f7a90adb 61 fields · synced Jul 13, 2026
- FDA UDI 93ef1ea3-0d20-40fc-9e02-06c56ab89dc1 36 fields · synced May 29, 2026