Identity
- Trade Name
- DSG® Threaded shaft EUDAMEDPEDIGUARD THREADED FDA UDI
- Generic Name
- Manual surgical rotary handpiece, reusable FDA UDI
- Device Name
- DSG Threaded Shaft B - Ø4.5mm EUDAMED
- Model / Reference
- D1TAXXXX EUDAMEDD1TA0011 EUDAMEDDSG Threaded Shaft B - Ø4.5mm FDA UDI
Identifiers
- Catalog Number
- D1TA0011 FDA UDI
- Primary DI / UDI-DI
- 03662674000327 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03662674000327 EUDAMED
- FDA Product Code
- PDQ FDA UDI
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
- GMDN Term
- Manual surgical rotary handpiece, reusable FDA UDI
Classification
- Device Class
- Class I 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
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
DSG® Threaded shaft by SpineGuard.S.A — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-03662674000327 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SpineGuard.S.A
- EUDAMED SRN
- FR-MF-000004720
Sources (2)
- EUDAMED 05d1ebd3-0ba6-43ee-9edd-1b44152cea5a 61 fields · synced Jul 9, 2026
- FDA UDI 64ee2575-2d97-4da0-949e-18ee31b52916 34 fields · synced May 27, 2026