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Drill Ø3.2 x 146 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T827Model Straight Drill Bits
Identity
- Trade Name
- Drill Ø3.2 x 146 mm EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Model / Reference
- Straight Drill Bits EUDAMEDT827 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- T827 FDA UDI
- Primary DI / UDI-DI
- 07640187918076 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018791DRILLSTR01LZ EUDAMED
- Direct Marketing DI
- 07640187918076 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Austria 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
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
Yes
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
Drill Ø3.2 x 146 mm by MPS Micro Precision Systems AG — 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 | 764018791DRILLSTR01LZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MPS Micro Precision Systems AG
- EUDAMED SRN
- CH-MF-000032439
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1752bdd3-f1e2-4036-8eac-068c87ad4fa0 61 fields · synced Jul 30, 2026
- FDA UDI bc39dd96-af07-441f-ad75-ad6ce09a9c13 34 fields · synced May 30, 2026