Titanium Bipolar Coagulation Forceps 6 in. (15.0cm) Straight 0.5mm tip
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Kirwan FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Titanium Bipolar Coagulation Forceps 6 in. (15.0cm) Straight 0.5mm tip EUDAMEDTitanium Bipolar Coagulation Forceps 6" (15cm) Straight 0.5mm Tip FDA UDI
- Model / Reference
- 15-5112 EUDAMEDFDA UDI
- Description
- Titanium Bipolar Coagulation Forceps 6" (15cm) Straight 0.5mm Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019103944 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841019103944 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180401 OPEN ELECTROSURGERY FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable 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
No
Single Use
No
Implantable
No
Reusable
Yes
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
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 6 Inch FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Titanium Bipolar Coagulation Forceps 6 in. (15.0cm) Straight 0.5mm tip by Kirwan Surgical Products Llc — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, reusable.
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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-00841019103944 | 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 4aef3bc6-6943-4a38-8fa8-f5acbc00960a 61 fields · synced Oct 6, 2026
- FDA UDI beded576-2d65-4304-92a8-f52af1c68cf7 35 fields · synced May 30, 2026