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 80mm FDA UDI
- Model / Reference
- GLC80 EUDAMEDFDA UDI
- Description
- Echelon Linear Cutter 80mm FDA UDI
Identifiers
- Catalog Number
- GLC80 FDA UDI
- Primary DI / UDI-DI
- 10705036030881 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 4b0d58ff-d1c1-4d39-9872-5a233e7d96b9 61 fields · synced Jun 9, 2026
- FDA UDI 6ff99018-b36a-47f5-9728-fc13271ce726 36 fields · synced May 30, 2026