Identity
- Trade Name
- ENDOPATH FDA UDI
- Generic Name
- Endoscopic manual linear stapler FDA UDI
- Device Name
- Endopath ETS Flex45 No-Knife Endoscopic Articulating Linear Stapler, 45mm FDA UDI
- Model / Reference
- NAW45 FDA UDI
- Description
- Endopath ETS Flex45 No-Knife Endoscopic Articulating Linear Stapler, 45mm FDA UDI
Identifiers
- Catalog Number
- NAW45 FDA UDI
- Primary DI / UDI-DI
- 20705036002533 FDA UDI
- FDA Product Code
- GDW FDA UDI
- GMDN Term
- Endoscopic manual linear stapler FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Endopath by Ethicon Endo-Surgery, Inc. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K942450 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, Inc.
Sources (2)
- FDA UDI 57a1454d-4690-4335-b30b-917d2e95f4d3 60 fields · synced Jun 19, 2026
- FDA 510(k) K942450 1 fields · synced May 29, 2026