Endopath
by Johnson & Johnson Medical GmbH EUDAMEDGUDID
Active
Ref SRNH1
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0705031a0080553 | Date30 Sep 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10705031135444 | Date1 Jul 2016 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- Generic Name
- Suturing needle holder, reusable
- Device Name
- ENDOPATH Endoscopic Needle Holder
- Model / Ref / Catalog
- SRNH1
- Primary DI / UDI-DI
- 10705031135444
- Basic UDI-DI
- 0705031a0080553
- FDA Product Code
- GCJ
- EMDN Code
- L1205 Laparoscopic and thoracoscopic surgery needle holders, reusable
- GMDN Term
- Suturing needle holder, reusable
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 876.1500
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- DE-MF-000007714
Other devices from Johnson & Johnson Medical GmbH
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No