Disposable Bipolar Pencil 25 Gauge Straight
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Kirwan FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- Disposable Bipolar Pencil 25 Gauge Straight EUDAMEDDisposable Bipolar Pencil 25 Gauge Straight (Nidek Distributor) FDA UDI
- Model / Reference
- 19241-M979 EUDAMED18241-M979 EUDAMEDFDA UDI
- Description
- Disposable Bipolar Pencil 25 Gauge Straight (Nidek Distributor) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019112595 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841019112595 EUDAMED
- 510(k) Number
- K864402 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Disposable Bipolar Pencil 25 Gauge Straight by Kirwan Surgical Products Llc — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00841019112595 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Kirwan Surgical Products LLC
- EUDAMED SRN
- US-MF-000008222
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED 8dcb17d5-dfbf-4338-be39-ba09b74e94b8 61 fields · synced Jul 29, 2026
- FDA UDI add0bca1-d2ea-4cb4-9098-12cae13aa870 35 fields · synced May 30, 2026