Identity
- Trade Name
- Innara Health FDA UDI
- Generic Name
- Evoked-potential graphic recording system FDA UDI
- Device Name
- Handpiece Tubing, NTrainer System 2.0 (Qty 2) FDA UDI
- Model / Reference
- IN-5002 FDA UDI
- Description
- Handpiece Tubing, NTrainer System 2.0 (Qty 2) FDA UDI
Identifiers
- Catalog Number
- IN-5002 FDA UDI
- Primary DI / UDI-DI
- 00860009695221 FDA UDI
- 510(k) Number
- K071866 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Evoked-potential graphic recording system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 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
Yes
FDA UDI
Category: Evoked-potential graphic recording system
Innara Health by Innara Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K071866 also covers:
- Innara Health — INNARA HEALTH, INC.
- Innara Health — INNARA HEALTH, INC.
- Innara Health — INNARA HEALTH, INC.
- Innara Health — INNARA HEALTH, INC.
- Innara Health — INNARA HEALTH, INC.
- Innara Health — INNARA HEALTH, INC.
- NTrainer — INNARA HEALTH, INC.
- NTrainer — INNARA HEALTH, INC.
- NTrainer — INNARA HEALTH, INC.
- NTrainer — INNARA HEALTH, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Innara Health, Inc.
Sources (1)
- FDA UDI 0c97fcb5-6354-4f83-a289-0f454ba98be7 35 fields · synced Jun 8, 2026