Identity
- Trade Name
- FLEXIPATH EUDAMEDFDA UDI
- Generic Name
- Subcutaneous tunneller, single-use FDA UDI
- Device Name
- Flexipath Flexible Surgical Trocar Paks FDA UDI
- Model / Reference
- FPK02 EUDAMEDFDA UDI
- Description
- Flexipath Flexible Surgical Trocar Paks FDA UDI
Identifiers
- Catalog Number
- FPK02 FDA UDI
- Primary DI / UDI-DI
- D-USMF000013107000061MF EUDAMED10705036001997 FDA UDI
- Basic UDI-DI
- B-USMF000013107000061MF EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01010101,K01010104 EUDAMED
- GMDN Term
- Subcutaneous tunneller, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
Flexipath 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-USMF000013107000061MF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED 2a13f4e6-eba3-46c0-af57-a01c4f3c5d37 61 fields · synced Sep 17, 2026
- FDA UDI 50586119-f15c-4daf-a569-f25fd05347e3 35 fields · synced May 30, 2026