Identity
- Trade Name
- ENDOPATH XCEL EUDAMEDFDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- ENDOPATH XCEL Trocars EUDAMEDEndopath XCEL Bladeless Trocars with Stability Sleeves FDA UDI
- Model / Reference
- B12LT EUDAMEDFDA UDI
- Description
- Endopath XCEL Bladeless Trocars with Stability Sleeves FDA UDI
Identifiers
- Catalog Number
- B12LT FDA UDI
- Primary DI / UDI-DI
- 10705036001164 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000636W EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01010199 TROCAR, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Laparoscopic access cannula, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
No
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
Endopath Xcel by Ethicon Endo-Surgery, LLC — Class IIa — 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 | 0705036a000636W | 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 58124360-4e42-46e2-9313-fc9d1b6711b8 61 fields · synced Jul 25, 2026
- FDA UDI c0ca3b94-f388-45ac-be64-7d7434944c07 35 fields · synced May 30, 2026