Identity
- Trade Name
- PediGuard EUDAMEDPEDIGUARD CLASSIC FDA UDI
- Generic Name
- Bone awl, single-use FDA UDI
- Device Name
- PediGuard Gearshift EUDAMED
- Model / Reference
- P1-AUXXX EUDAMEDP1-AU411 EUDAMEDPEDIGUARD TRI TIP 4.0mm FDA UDI
Identifiers
- Catalog Number
- P1-AU411 FDA UDI
- Primary DI / UDI-DI
- 03662674000006 EUDAMEDFDA UDI
- Basic UDI-DI
- 3662674P1AUXXXYJ EUDAMED
- Direct Marketing DI
- 03662674000006 EUDAMED
- 510(k) Number
- K143159 FDA UDI
- FDA Product Code
- ETN FDA UDIPDQ FDA UDI
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
- GMDN Term
- Bone awl, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1820 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
- Outer Diameter — 4.0 Millimeter FDA UDILength — 55 Millimeter FDA UDI
PediGuard by SpineGuard.S.A — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3662674P1AUXXXYJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SpineGuard.S.A
- EUDAMED SRN
- FR-MF-000004720
Sources (2)
- EUDAMED d5cba2c6-1111-420d-a86b-6055a2711c86 61 fields · synced Jun 8, 2026
- FDA UDI fb41e7c5-0b6b-4e00-b4ad-cc0953ab7e60 37 fields · synced May 30, 2026