Identity
- Trade Name
- Universal Dilator FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- Wrench FDA UDI
- Model / Reference
- 52-03-12 FDA UDI
- Description
- Wrench FDA UDI
Identifiers
- Catalog Number
- 523-0012 FDA UDI
- Primary DI / UDI-DI
- M7405230012 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical torque wrench, 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 Unsafe FDA UDI
Category: Surgical torque wrench, reusable
Universal Dilator by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- X FIX — Biomet Orthopedics, Inc. · Class I
- BIONNOVATION — BIONNOVATION PRODUTOS BIOMEDICOS LTDA. · 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 e26f4857-434c-437d-af4c-11b0b0ab9e4d 35 fields · synced Jun 1, 2026