2.2 Cannulated Twist Drill Ø1.9, L87mm, AO
Ref A-3741S
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Overview
A comprehensive medical device directory, featuring the 2.2 Cannulated Twist Drill Ø1.9, AO. This instrument is designed for rotating and cutting instruments that are connected to an active device. Its primary use is in implantable medical devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number76300378015PD 07630894810527 | Date6 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07630894810527 | Date10 Apr 2024 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- 2.2 Cannulated Twist Drill Ø1.9,L87mm,AO EUDAMEDAptus GUDID
- Generic Name
- Orthopaedic bur, single-use
- Device Name
- Rotating and cutting instruments (connected to an active device)
- Model / Ref / Catalog
- A-3741S
- Primary DI / UDI-DI
- 07630894810527
- Basic UDI-DI
- 76300378015PD
- FDA Product Code
- HTW
- EMDN Code
- Z12130503 Orthopaedic surgical drills
- GMDN Term
- Orthopaedic bur, single-use
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 888.4540
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- CH-MF-000022291
- Authorised representative
- Medartis GmbH DE-AR-000005810
Other devices from Medartis AG
Properties
Other properties (17)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No