Identity
- Trade Name
- Trocar Tip Guide Wire FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- Trocar Tip Guide Wire, 1.6mm x 500mm (Threaded) FDA UDI
- Model / Reference
- ODID105 FDA UDI
- Description
- Trocar Tip Guide Wire, 1.6mm x 500mm (Threaded) FDA UDI
Identifiers
- Catalog Number
- ODI-D105 FDA UDI
- Primary DI / UDI-DI
- B058ODID1051 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic guidewire, single-use 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 500 Millimeter FDA UDIOuter Diameter — 1.6 Millimeter FDA UDI
Category: Orthopaedic guidewire, single-use
Trocar Tip Guide Wire by Orthopedic Designs North America, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic guidewire, single-use.
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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
- Orthopedic Designs North America, Inc.
Sources (1)
- FDA UDI 440dda84-b622-4a3e-a56a-92213d419af7 36 fields · synced May 31, 2026