Identity
- Trade Name
- K-Wire Stimulation Lead, Sterile EUDAMEDGlobus FDA UDI
- Generic Name
- Analytical non-scalp cutaneous lead FDA UDI
- Device Name
- Sterile Electrode Cables EUDAMEDK-wire Stimulation Lead, Sterile 1 pc FDA UDI
- Model / Reference
- 693.061S EUDAMEDFDA UDI
- Description
- K-wire Stimulation Lead, Sterile 1 pc FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375866979 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375866979 EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous lead FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
K-Wire Stimulation Lead, Sterile by Technomed Europe — 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-08718375866979 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (2)
- EUDAMED 90af3485-f8b5-450a-8fff-5a9caf2ebc45 61 fields · synced Jun 18, 2026
- FDA UDI 88e9e7bc-8bf0-4327-8b98-d92426c38dea 34 fields · synced May 30, 2026