Identity
- Trade Name
- DRLock FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- FIXED DRILL GUIDE WITH DEPTH GAUGE FDA UDI
- Model / Reference
- DRE-071-19-FDG FDA UDI
- Description
- FIXED DRILL GUIDE WITH DEPTH GAUGE FDA UDI
Identifiers
- Catalog Number
- DRE-071-19-FDG FDA UDI
- Primary DI / UDI-DI
- 00846832031337 FDA UDI
- FDA Product Code
- HTJ FDA UDI
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4300 FDA UDI
- Commercial Distribution
- Not 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
DRLock by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Tornier, Inc.
Sources (1)
- FDA UDI fcf72af8-259f-4187-bf55-6929059b7cba 36 fields · synced May 30, 2026