Identity
- Trade Name
- ForeFoot STP FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Device Name
- Cannulated Depth Gage FDA UDI
- Model / Reference
- FHS-059L FDA UDI
- Description
- Cannulated Depth Gage FDA UDI
Identifiers
- Catalog Number
- FHS-059L FDA UDI
- Primary DI / UDI-DI
- 00846832063956 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
ForeFoot STP is a cannulated depth gauge designed to measure the depth of recesses in bone for surgical procedures. This device features a moveable centrepiece, a prong tip that reads from a scale, and a circular disc with a central hole clipped to a drill bit. It is a reusable instrument intended for implantation, typically used in orthopedic surgeries.
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 b89017f2-1514-49c1-813d-6f2dc3632df6 37 fields · synced Jul 22, 2026