DISPOSABLE IRRIGATION BIPOLAR CORD 38mm
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Kirwan FDA UDI
- Generic Name
- Electrical-only medical device connection cable, single-use FDA UDI
- Device Name
- DISPOSABLE IRRIGATION BIPOLAR CORD 38mm EUDAMEDFDA UDI
- Model / Reference
- 10-4601J EUDAMEDFDA UDI
- Description
- Disposable Irrigation Bipolar Cord 38mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019101834 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841019101834 EUDAMED
- 510(k) Number
- K831236 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K02010203 ELECTROSURGERY CONNECTION CABLES, SINGLE-USE EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, single-use 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
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: Electrical-only medical device connection cable, reusable
DISPOSABLE IRRIGATION BIPOLAR CORD 38mm by Kirwan Surgical Products Llc — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-00841019101834 | 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 03737839-cec9-4b4f-a457-8c737b7f5612 61 fields · synced Jul 9, 2026
- FDA UDI a6404fab-244f-47a5-877e-7192cad156b4 35 fields · synced May 30, 2026