Identity
- Trade Name
- ENDOPATH EUDAMEDFDA UDI
- Generic Name
- Spring-loaded pneumoperitoneum needle, single-use FDA UDI
- Device Name
- ENDOPATH Insufflation Needles EUDAMEDEndopath Pneumoneedle Insufflation Needles with Luer Lock Connectors 150mm FDA UDI
- Model / Reference
- PN150 EUDAMEDFDA UDI
- Description
- Endopath Pneumoneedle Insufflation Needles with Luer Lock Connectors 150mm FDA UDI
Identifiers
- Catalog Number
- PN150 FDA UDI
- Primary DI / UDI-DI
- 10705036012979 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a0006776 EUDAMED
- 510(k) Number
- K910875 FDA UDI
- FDA Product Code
- FDP FDA UDI
- EMDN Code
- K0104 VERESS NEEDLES EUDAMED
- GMDN Term
- Spring-loaded pneumoperitoneum needle, 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
Yes
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 — 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 | 0705036a0006776 | 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 303c5352-247f-4c71-b30e-fda2f6bb758f 61 fields · synced Jul 8, 2026
- FDA UDI 12795e88-a69a-4983-a73a-6f89590f6583 36 fields · synced May 30, 2026