Identity
- Trade Name
- DSG Threaded Shaft EUDAMEDPEDIGUARD THREADED FDA UDI
- Generic Name
- Manual surgical rotary handpiece, reusable FDA UDI
- Device Name
- DSG Threaded Shaft EUDAMED
- Model / Reference
- D1TAXXXX EUDAMEDD1TA0021 EUDAMEDDSG Threaded Shaft L Ø4.5mm FDA UDI
Identifiers
- Catalog Number
- D1TA0021 FDA UDI
- Primary DI / UDI-DI
- 03662674000563 EUDAMEDFDA UDI
- Basic UDI-DI
- 3662674D1TAXXXXZL EUDAMED
- Direct Marketing DI
- 03662674000563 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
DSG Threaded Shaft by SpineGuard.S.A — Class I — 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 | 3662674D1TAXXXXZL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SpineGuard.S.A
- EUDAMED SRN
- FR-MF-000004720
Sources (2)
- EUDAMED 0021cd00-92c1-4e8c-94e9-5f44844810c0 61 fields · synced Jul 9, 2026
- FDA UDI 6374b230-1b15-4de2-bfa8-0aff873eee32 34 fields · synced May 30, 2026