Hu-Friedy
by Hu-Friedy Manufacturing Co., LLC United States EUDAMEDGUDID
Ref GCPG76Model Dental Device
Product code MDMEMDN L1506
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0889950Place1RU | Date1 Jul 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10889950013097 | Date12 Nov 2020 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Dental spatula, reusable
- Model / Ref / Catalog
- Dental Device, GCPG76
- Primary DI / UDI-DI
- 10889950013097
- Basic UDI-DI
- 0889950Place1RU
- FDA Product Code
- MDM
- EMDN Code
- L1506 Odontostomatology obturators, reusable
- GMDN Term
- Dental spatula, reusable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
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 7f698b1d-2762-4217-9a5d-736cb880fd4e
- FDA UDI 4f09052f-1804-490c-a090-4863148a0081