Identity
- Trade Name
- Kirwan FDA UDI
- Generic Name
- Electrosurgical handpiece, reusable FDA UDI
- Device Name
- Reusable Monopolar Chuck Handle EUDAMEDReusable Monopolar Chuck Handle 8 1/2" (21.6cm) with 10 ft. (3m) Silicone Cord FDA UDI
- Model / Reference
- 30-4004 EUDAMEDFDA UDI
- Description
- Reusable Monopolar Chuck Handle 8 1/2" (21.6cm) with 10 ft. (3m) Silicone Cord FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019107355 EUDAMEDFDA UDI
- Basic UDI-DI
- 08410191MCH1072A EUDAMED
- 510(k) Number
- K864771 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Electrosurgical handpiece, reusable FDA UDI
Classification
- Device Class
- Class I 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
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
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 — 8.5 Inch FDA UDI
Category: Electrical-only medical device connection cable, reusable
Reusable Monopolar Chuck Handle by Kirwan Surgical Products Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08410191MCH1072A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 61f7edad-247f-4964-966f-e52d045ecce5 61 fields · synced Jul 18, 2026
- FDA UDI 0ffe6bf8-e2de-436a-a1d4-1822cb0a72a1 36 fields · synced May 29, 2026