Identity
- Trade Name
- Made-To-Order FDA UDI
- Generic Name
- Orthopaedic implant calibration pin FDA UDI
- Device Name
- Perform Pin Guide +3 FDA UDI
- Model / Reference
- 9027415 FDA UDI
- Description
- Perform Pin Guide +3 FDA UDI
Identifiers
- Catalog Number
- 9027415 FDA UDI
- Primary DI / UDI-DI
- 00846832097210 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Orthopaedic implant calibration pin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant calibration pin
A comprehensive guide to the Made-To-Order Orthopaedic implant calibration pin, a precision device used preoperatively as a reference point for aligning orthopaedic implants. This device is designed to ensure accurate placement and proper alignment of the implant, which is critical for successful surgery.
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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
- Tornier, Inc.
Sources (1)
- FDA UDI aee4d643-dc85-404f-a9cf-04da4a3f6bdb 36 fields · synced Oct 6, 2026