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Twist Drill Ø2.35mm x 38mm, L151mm, AO
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A-3837S
by Medartis AG
Identity
- Trade Name
- Twist Drill Ø2.35mm x 38mm, L151mm, AO EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- Rotating and cutting instruments (connected to an active device) EUDAMEDTwist Drill Ø2.35mm x 38mm, L151mm, AO FDA UDI
- Model / Reference
- A-3837S EUDAMEDFDA UDI
- Description
- Twist Drill Ø2.35mm x 38mm, L151mm, AO FDA UDI
Identifiers
- Catalog Number
- A-3837S FDA UDI
- Primary DI / UDI-DI
- 07630037865889 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378015PD EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
- GMDN Term
- Orthopaedic bur, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
Twist Drill Ø2.35mm x 38mm, L151mm, AO by Medartis 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 | 76300378015PD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medartis AG
- EUDAMED SRN
- CH-MF-000022291
- Authorised Representative
- Medartis GmbH DE-AR-000005810
Sources (2)
- EUDAMED 6a414304-75f2-48fd-bc34-27d284921429 61 fields · synced Jun 18, 2026
- FDA UDI 0171aebd-1b7c-4906-ab67-c45e4cb9bb48 34 fields · synced May 29, 2026