Identity
- Trade Name
- primaLOK FF FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- EMG Cannula FDA UDI
- Model / Reference
- 800-1206 FDA UDI
- Description
- EMG Cannula FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813210022096 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Endoscopic-access dilator, reusable 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 Conditional FDA UDI
Category: Endoscopic-access dilator, reusable
primaLOK FF by Wenzel Spine — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic-access dilator, reusable.
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- iLESSYS® — JOIMAX, INC. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- TESSYS® — JOIMAX, INC. · 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
- Wenzel Spine
Sources (1)
- FDA UDI 52557024-d317-4793-be86-c88da30a96b1 34 fields · synced May 29, 2026