Identity
- Trade Name
- Columbia Scientific FDA UDI
- Generic Name
- Transcutaneous electrical stimulation lead FDA UDI
- Device Name
- Columbia 06 set of lead wires with clips to be used with Columbia 600 electrodes FDA UDI
- Model / Reference
- Columbia 06 FDA UDI
- Description
- Columbia 06 set of lead wires with clips to be used with Columbia 600 electrodes FDA UDI
Identifiers
- Catalog Number
- Columbia 06 FDA UDI
- Primary DI / UDI-DI
- 00850243006167 FDA UDI
- 510(k) Number
- K080386 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation lead FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation lead
Columbia Scientific by Columbia Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080386 also covers:
- Columbia Scientific — Columbia Scientific, Inc.
- Columbia Scientific — Columbia Scientific, Inc.
- Columbia Scientific — Columbia Scientific, Inc.
- Columbia Scientific — Columbia Scientific, Inc.
- Columbia Scientific — Columbia Scientific, Inc.
- Columbia Scientific — Columbia Scientific, Inc.
- Columbia Scientific — Columbia Scientific, Inc.
- Columbia Scientific — Columbia Scientific, Inc.
- Columbia Scientific — Columbia Scientific, Inc.
- Columbia Scientific — Columbia Scientific, Inc.
- Columbia Scientific — Columbia Scientific, Inc.
- Columbia Scientific — Columbia Scientific, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Columbia Scientific, Inc.
Sources (1)
- FDA UDI 5ef7868e-04cf-4cfa-aa95-aa4f81791b58 36 fields · synced May 30, 2026