Identity
- Trade Name
- OptiLIF Endo, Direct Visualization System FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- 180mm x 7.5mm Tube FDA UDI
- Model / Reference
- 102-31-04 FDA UDI
- Description
- 180mm x 7.5mm Tube FDA UDI
Identifiers
- Catalog Number
- 100-1267 FDA UDI
- Primary DI / UDI-DI
- M7401001267 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Spinal endoscopic-access system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Spinal endoscopic-access system
OptiLIF Endo, Direct Visualization System by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal endoscopic-access system.
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- Trephine — ELLIQUENCE LLC · Class I
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- Medfix — Medfix International, LLC · Class I
- Working Tube — ELLIQUENCE LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI 1208b25c-1f0d-4607-b319-1b806a832894 35 fields · synced May 31, 2026