Identity
- Trade Name
- Osteotec Silicone Finger Implant Sizer Size 00 FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- The Osteotec Silicone Finger Implant Sizer is a one-piece, blue flexible silicone elastomer device with the same dimensions as the Osteotec Silicone Finger Implant. The sizers are used initially as a guide to choosing the correct size of implant and then, once that choice is made, to insert into the prepared joint space to enable the surgeon to check fit and function e.g. range of motion FDA UDI
- Model / Reference
- OSTF-S00 FDA UDI
- Description
- The Osteotec Silicone Finger Implant Sizer is a one-piece, blue flexible silicone elastomer device with the same dimensions as the Osteotec Silicone Finger Implant. The sizers are used initially as a guide to choosing the correct size of implant and then, once that choice is made, to insert into the prepared joint space to enable the surgeon to check fit and function e.g. range of motion FDA UDI
Identifiers
- Catalog Number
- OSTF-S00 FDA UDI
- Primary DI / UDI-DI
- 05060183090163 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant/trial-implant/sizer holder, reusable
Osteotec Silicone Finger Implant Sizer Size 00 by Osteotec, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Osteotec, Ltd.
Sources (1)
- FDA UDI 1dd39b57-0426-4c95-ad1f-45e500d72176 34 fields · synced May 30, 2026