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PediGuard DSG Connect Ø2.5 XS
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P1-AU514Model P1-AUXXX
Identity
- Trade Name
- PediGuard DSG Connect Ø2.5 XS EUDAMEDPediGuard DSG Connect FDA UDI
- Generic Name
- Bone awl, single-use FDA UDI
- Device Name
- PediGuard Gearshift EUDAMED
- Model / Reference
- P1-AUXXX EUDAMEDP1-AU514 EUDAMEDPediGuard DSG Connect Ø2.5 XS FDA UDI
Identifiers
- Catalog Number
- P1-AU514 FDA UDI
- Primary DI / UDI-DI
- 03662674000518 EUDAMEDFDA UDI
- Basic UDI-DI
- 3662674P1AUXXXYJ EUDAMED
- Direct Marketing DI
- 03662674000518 EUDAMED
- 510(k) Number
- K201454 FDA UDI
- FDA Product Code
- PDQ FDA UDIETN FDA UDIHBG 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 UDI882.4300 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
No
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
PediGuard DSG Connect Ø2.5 XS 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 c74279cc-afb8-4279-8c6b-e53c4bb4e474 61 fields · synced Jun 17, 2026
- FDA UDI 5d8c8580-30e6-4d96-be8a-42e01be9d8dd 35 fields · synced May 30, 2026