Non-Stick
by Kirwan Surgical Products LLC United States EUDAMEDGUDID
Ref 10-3200NS
Product code GEIEMDN L180301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00841019101537 | Date8 Nov 2021 | StatusActive |
| United States | GUDID listing GUDID | Number00841019101537 | Date4 Apr 2016 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Non-Stick EUDAMEDKirwan GUDID
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
- Device Name
- 4" JEWELERS STRAIGHT NON-STICK BIPOLAR FORCEPS, 0.4mm TIP
- Model / Reference
- 10-3200NS
- Primary DI / UDI-DI
- 00841019101537
- Basic UDI-DI
- B-00841019101537
- 510(k) Number
- FDA Product Code
- GEI
- EMDN Code
- L180301 Open electrosurgery handpieces, reusable
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 878.4400
- Market of Registration
- Germany
- Commercial Distribution
- 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 & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED 1e44c5c2-49a3-4e39-aadc-396a74c14b7d
- FDA UDI d2778a34-387d-46d1-b27e-6afe688bb54e