Disposable Impression Tray
by G&H Wire Company, Inc. EUDAMEDGUDID
Active
Ref DITAS
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number10190886135945 | Date9 Oct 2023 | StatusListed |
| European Union | CE/MDR EUDAMED | Number0190886DispImpTraysGE | Date13 Jul 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- Dental impression tray, single-use
- Device Name
- Disposable Impression Tray
- Model / Reference
- DITAS
- Primary DI / UDI-DI
- 10190886135945
- Basic UDI-DI
- 0190886DispImpTraysGE
- Unit of Use DI
- 00190886135948
- FDA Product Code
- EHY
- EMDN Code
- Q010503 Impression material trays, single-use
- GMDN Term
- Dental impression tray, single-use
- Device Class
- Class I
- Regulation Number
- 872.6880
- Market of Registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- US-MF-000012129
- Authorised representative
- G&H Europe BV NL-AR-000022839
Other devices from G&H Wire Company, Inc.
Properties
Other properties (19)
- Sterile: 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No