Y-Knot
by Conmed Corporation United States EUDAMEDGUDID
Ref Y18D
Product code GFGEMDN P091303
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-10845854021682 | Date2 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10845854021682 | Date30 May 2021 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Fluted surgical drill bit, single-use
- Device Name
- Non-orthopedic, Non-active, Instrument, Endoscopic, Biopsy Forceps
- Model / Ref / Catalog
- Y18D
- Primary DI / UDI-DI
- 10845854021682
- Basic UDI-DI
- B-10845854021682
- FDA Product Code
- GFG
- EMDN Code
- P091303 Orthopaedic implant drill bits, single-use
- GMDN Term
- Fluted surgical drill bit, single-use
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 878.4820
- Market of Registration
- Belgium
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000012663
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Conmed Corporation
Properties & raw data
Show properties, registry sources and raw records
Other properties (18)
- 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
- Manufacturing Date: No
Sources (2)
- EUDAMED 7cf9ad88-f788-4482-bd0f-c2e4689b2ab8
- FDA UDI 3088986f-0c47-49a4-9c3b-19ed9c0d4e67