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Twist Drill Ø1.6mm x 25mm, L87mm, Stryker
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref A-3420SRef A-3420
by Medartis AG
Identity
- Trade Name
- Twist Drill Ø1.6mm x 25mm, L87mm,Stryker EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- Rotating and cutting instruments (connected to an active device) EUDAMEDTwist Drill Ø1.6mm x 25mm, L87mm,Stryker FDA UDI
- Model / Reference
- A-3420S EUDAMEDA-3420 EUDAMEDFDA UDI
- Description
- Twist Drill Ø1.6mm x 25mm, L87mm,Stryker FDA UDI
Identifiers
- Catalog Number
- A-3420 FDA UDI
- Primary DI / UDI-DI
- 07630037865285 EUDAMED07630037865278 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378015PD EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
- GMDN Term
- Orthopaedic bur, reusable 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
EUDAMEDEUDAMEDFDA UDI
Single Use
No
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
Moist Heat or Steam Sterilization FDA UDI
Twist Drill Ø1.6mm x 25mm, L87mm, Stryker 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 (3)
- EUDAMED 79850bc3-9237-4c54-9a3b-5199eb75f536 61 fields · synced Jul 11, 2026
- EUDAMED ce30c525-cf60-4971-b792-a69eaf8cdb5c 61 fields · synced May 17, 2026
- FDA UDI 08d7b21e-af9b-4ba6-a96b-3d2b0a9e5833 34 fields · synced May 30, 2026