Na 899601095
Ref 89960.1095Model 10000201363
Active
CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-04055207072028 | Date16 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04055207047194 | Date12 Aug 2022 | 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- Withdrawn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
- Generic Name
- Cannulated surgical drill bit, reusable
- Device Name
- Head drills for motorized use
- Model / Ref / Catalog
- 10000201363, 89960.1095, 899601095
- Description
- HEAD DRILL Ø 9.5MM cannulated Ø 2.65 mm, PACK = 1 PC, TIN coating, WL 145 mm, reusable
- Primary DI / UDI-DI
- 04055207047194, 04055207072028
- Basic UDI-DI
- B-04055207072028, B-04055207047194
- FDA Product Code
- HWE
- EMDN Code
- Z12130503 Orthopaedic surgical drills
- GMDN Term
- Cannulated surgical drill bit, reusable
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 878.4820
- EU market of registration
- Germany
- GUDID distribution status
- Not in Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- Size
- Outer Diameter — 9.5 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 10000201363 89960.1095 | 899601095 |
| Device Class | Class IIa | Class I |
Other devices from Richard Wolf GmbH
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No