Identity
- Trade Name
- 10mm Twist Subtalar Trial FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Model / Reference
- 112-10-010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812926020440 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical implant template, 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
Category: Surgical implant template, reusable
A comprehensive medical device designed to determine the appropriate size and placement of a non-dental implant for patients prior to or during surgery, utilizing a graduated set or individual plate with patterns/sizes corresponding to the size of the implant.
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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
- Trilliant Surgical LLC
Sources (1)
- FDA UDI a4470e46-c88a-4703-9735-33a6a45742a5 32 fields · synced Jul 24, 2026