Hu-Friedy
by Hu-Friedy Manufacturing Co., LLC United States EUDAMEDGUDID
Ref RDCM7XModel Dental Devices
Product code EEFEMDN L15901102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0889950Hold1H4 | Date26 Jun 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10889950105013 | Date14 Aug 2020 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Rubber dam clamp
- Model / Ref / Catalog
- Dental Devices, RDCM7X
- Primary DI / UDI-DI
- 10889950105013
- Basic UDI-DI
- 0889950Hold1H4
- FDA Product Code
- EEF
- EMDN Code
- L15901102 Dam positioning instruments, reusable
- GMDN Term
- Rubber dam clamp
- Device Class
- Class I
- Regulation Number
- 872.6300
- 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 7ecd306b-ec7c-4037-bacb-4004a24372c0
- FDA UDI 8eb79bf6-31eb-450f-85eb-48f51f3fa343