Irrigating Bipolar Coagulation Forceps 8 3/4 in. (22.2cm) Hardy Bayonet Insulat…
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Kirwan FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Irrigating Bipolar Coagulation Forceps 8 3/4 in. (22.2cm) Hardy Bayonet Insulated w/stops, 0.5mm tip EUDAMEDIrrigating Bipolar Coagulation Forceps 8 3/4" (22.2cm) Hardy Bayonet Insulated w/stops, 0.5mm Tip FDA UDI
- Model / Reference
- 12-1335 EUDAMEDFDA UDI
- Description
- Irrigating Bipolar Coagulation Forceps 8 3/4" (22.2cm) Hardy Bayonet Insulated w/stops, 0.5mm Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019102855 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841019102855 EUDAMED
- 510(k) Number
- K811820 FDA UDI
- 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 — 8.75 Inch FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Irrigating Bipolar Coagulation Forceps 8 3/4 in. (22.2cm) Hardy Bayonet Insulat… by Kirwan Surgical Products Llc — Class IIb — MDD, FDA UDI — listed in…
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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-00841019102855 | 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 edbf07b7-1f47-4eae-bdb6-e207e0bc9945 61 fields · synced Jul 31, 2026
- FDA UDI 303e55c2-bb50-403c-bf15-5808404d95b1 36 fields · synced May 30, 2026