Identity
- Trade Name
- ENDOPATH EUDAMEDFDA UDI
- Generic Name
- Subcutaneous tunneller, single-use FDA UDI
- Device Name
- Endopath Surgical Thoracic Trocar Sleeves with Rounded Tip Obturator FDA UDI
- Model / Reference
- TT012 EUDAMEDFDA UDI
- Description
- Endopath Surgical Thoracic Trocar Sleeves with Rounded Tip Obturator FDA UDI
Identifiers
- Catalog Number
- TT012 FDA UDI
- Primary DI / UDI-DI
- D-USMF000013107000067MT EUDAMED10705036013372 FDA UDI
- Basic UDI-DI
- B-USMF000013107000067MT EUDAMED
- FDA Product Code
- GEA FDA UDI
- EMDN Code
- K01010101,K01010104 EUDAMED
- GMDN Term
- Subcutaneous tunneller, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- 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 by Ethicon Endo-Surgery, LLC — Class IIa — 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-USMF000013107000067MT | 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 e15bc065-fa3e-448d-a6ca-2504e9c29919 61 fields · synced Jul 14, 2026
- FDA UDI 5eb993f5-dc61-483a-9ab2-40aa13cccfe8 35 fields · synced May 30, 2026