Identity
- Trade Name
- PEDIGUARD THREADED FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Model / Reference
- STARTER Pin 1 FDA UDI
Identifiers
- Catalog Number
- D1SP0001 FDA UDI
- Primary DI / UDI-DI
- 03662674000372 FDA UDI
- FDA Product Code
- GAH FDA UDI
- GMDN Term
- Bone awl, reusable 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 308 Millimeter FDA UDIOuter Diameter — 1.6 Millimeter FDA UDI
Category: Bone awl, reusable
Pediguard Threaded by Spineguard — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone awl, reusable.
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- CONMED — Conmed Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · 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
- Spineguard
Sources (1)
- FDA UDI bef40c32-fbf3-47e0-a9ee-8b4b0e85139c 36 fields · synced May 30, 2026