Liberty
by Kirwan Surgical Products LLC United States EUDAMEDGUDID
Ref 19-1231AUX
Product code GEIEMDN K0201010601
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00841019108949 | Date3 Dec 2021 | StatusActive |
| United States | GUDID listing GUDID | Number00841019108949 | Date25 Jun 2016 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Liberty EUDAMEDKirwan GUDID
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
- Device Name
- NON-STICK DISPOSABLE BIPOLAR FORCEPS 8 1/2 in. (21.6cm) Hardy Bayonet, Insulated, 2.0mm tip
- Model / Reference
- 19-1231AUX
- Primary DI / UDI-DI
- 00841019108949
- Basic UDI-DI
- B-00841019108949
- 510(k) Number
- FDA Product Code
- GEI
- EMDN Code
- K0201010601 Open electrosurgery forceps, single-use
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 878.4400
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Radiation Sterilization
- Size
- Length — 8.5 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 (17)
- Implantable: No
- Reusable: 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
- Manufacturing Date: No
Sources (2)
- EUDAMED 18900e25-3894-48f9-a0ea-53bbab2b55c6
- FDA UDI 2a1350dd-51c0-4fb2-b4e1-f03a54edfa48