Identity
- Trade Name
- ENDOSPINE FDA UDI
- Generic Name
- Spinal endoscopic-access system FDA UDI
- Device Name
- ENDOSPINE® Nerve Protector,Ø5mm,112mm FDA UDI
- Model / Reference
- 28163DPH FDA UDI
- Description
- ENDOSPINE® Nerve Protector,Ø5mm,112mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551099926 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Spinal endoscopic-access system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal endoscopic-access system
Endospine by Karl Storz GmbH & Co. KG — Class II — 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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- MaxView™ System - Posterior Set — VISEON, INC. · Class II
- Trephine — ELLIQUENCE LLC · Class I
- Kerrison — ELLIQUENCE LLC · Class I
- Medfix — Medfix International, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Karl Storz GmbH & Co. KG
Sources (1)
- FDA UDI 12b414cd-9220-4f90-953e-165a8084a967 33 fields · synced May 30, 2026