Hu-Friedy
by Hu-Friedy Manufacturing Co., LLC United States EUDAMEDGUDID
Ref SLL10/116Model Dental Device
Product code EMSEMDN L159001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0889950Remove1FA | Date4 Aug 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10889950029708 | Date30 Mar 2023 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Hu-Friedy EUDAMEDHu-Friedy MFG Co., LLC. GUDID
- Generic Name
- Periodontal curette
- Device Name
- #13/14 Gracey Curette Ex Rig #8 Hdl Clr
- Model / Reference
- Dental Device, SLL10/116
- Primary DI / UDI-DI
- 10889950029708
- Basic UDI-DI
- 0889950Remove1FA
- FDA Product Code
- EMS
- EMDN Code
- L159001 Dental and periodontal curettes, reusable
- GMDN Term
- Periodontal curette
- Device Class
- Class I
- Regulation Number
- 872.4565
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- US-MF-000017104
- Authorised representative
- Hu-Friedy Europe LLC & Co. KG DE-AR-000005530
Other devices from Hu-Friedy Manufacturing Co., LLC
Properties & raw data
Show properties, registry sources and raw records
Other properties (22)
- 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
- Manufacturing Date: No
Sources (2)
- EUDAMED 9a62aee5-3635-4814-bc5d-0a7a7f0de9ed
- FDA UDI 57f8bb95-0519-46c9-b3f5-fba5efd69e57