Identity
- Trade Name
- ACUFEX FDA UDI
- Generic Name
- Orthopaedic guidewire, reusable FDA UDI
- Device Name
- PCL SAFETY GUIDE WIRE REQUIRED CALIBRATED GUIDE WIRE USED IN CONJUNCTION WITH THE ACUFEX DIRECTOR PCL SAFETY STOP TO INDICATE WHEN THE TIP OF THE WIRE HAS PENETRATED THE POSTERIOR CORTEX FDA UDI
- Model / Reference
- 7207284 FDA UDI
- Description
- PCL SAFETY GUIDE WIRE REQUIRED CALIBRATED GUIDE WIRE USED IN CONJUNCTION WITH THE ACUFEX DIRECTOR PCL SAFETY STOP TO INDICATE WHEN THE TIP OF THE WIRE HAS PENETRATED THE POSTERIOR CORTEX FDA UDI
Identifiers
- Catalog Number
- 7207284 FDA UDI
- Primary DI / UDI-DI
- 03596010388254 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic guidewire, 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic guidewire, reusable
Acufex by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · Class I
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI f1cee90c-cbcb-4bda-bc94-c5781827bd95 35 fields · synced Jun 8, 2026