Identity
- Trade Name
- Needle #1 EUDAMEDCANNULATED PEDIGUARD FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- Cannulated PediGuard® Needle #1 EUDAMED
- Model / Reference
- P2ND1001 EUDAMEDCANNULATED PEDIGUARD NEEDLE 1 FDA UDI
Identifiers
- Catalog Number
- P2ND1001 FDA UDI
- Primary DI / UDI-DI
- 03662674000075 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03662674000075 EUDAMED
- 510(k) Number
- K143159 FDA UDI
- FDA Product Code
- ETN FDA UDIPDQ FDA UDI
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Bone access cannula 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
- Length — 160 Millimeter FDA UDIOuter Diameter — 3.0 Millimeter FDA UDI
Category: Orthopaedic guidewire, reusable
Needle #1 by SpineGuard.S.A — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03662674000075 | 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 46814336-0e11-448b-a941-8506a69a1b01 61 fields · synced Jun 8, 2026
- FDA UDI 950d371f-3d2e-45ba-8662-3f241dd19ed1 37 fields · synced May 30, 2026