Jeweler
by Kirwan Surgical Products LLC
Ref 10-3002
Active
CE MDD
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00841019101490 00841019101490 | Date28 Dec 2021 | StatusActive |
| United States | GUDID listing GUDID | Number00841019101490 | Date4 Apr 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Jeweler EUDAMEDKirwan GUDID
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
- Model / Reference
- 10-3002
- Primary DI / UDI-DI
- 00841019101490
- Basic UDI-DI
- B-00841019101490
- 510(k) Number
- FDA Product Code
- GEI
- EMDN Code
- L180401 Open electrosurgery forceps, reusable
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 878.4400
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- Size
- Length — 4 Inch
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000008222
- Authorised representative
- MPS Medical Product Service GmbH DE-AR-000005009
Other devices from Kirwan Surgical Products LLC
Properties
Other properties (18)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: 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