Monopolar Instrument cable with 8mm connector
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Monopolar Instrument cable with 8mm connector EUDAMEDMonppolar cable with 8mm connector FDA UDI
- Generic Name
- Electrical-only medical device connection cable, single-use FDA UDI
- Device Name
- Monopolar Instrument Cable EUDAMEDThe Monopolar Cables are for use with a variety of Monopolar instruments with a universal offset diathermy post connection & compatible for use with a wide variety of makes of electrosurgical diathermy generators. FDA UDI
- Model / Reference
- TF-1002 EUDAMEDPS3551C8 EUDAMEDFDA UDI
- Description
- The Monopolar Cables are for use with a variety of Monopolar instruments with a universal offset diathermy post connection & compatible for use with a wide variety of makes of electrosurgical diathermy generators. FDA UDI
Identifiers
- Catalog Number
- PS3551C8 FDA UDI
- Primary DI / UDI-DI
- 05051223005940 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051223005940 EUDAMED
- 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
- France 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
Dimensions & Sizes
- Size
- Length — 3 Meter FDA UDI
Category: Electrical-only medical device connection cable, reusable
Monopolar Instrument cable with 8mm connector by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK…
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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-05051223005940 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED a7c3e576-3dde-495f-96e6-e52dd72eb97e 61 fields · synced Jun 18, 2026
- FDA UDI 9fa15c0e-fb6f-4018-871b-f32812acedc8 36 fields · synced May 30, 2026