TrabEx
by MicroSurgical Technology Inc. United States EUDAMEDGUDID
Ref 600042
Product code HQCEMDN Q02010199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00844685003921 | Date3 Apr 2024 | StatusActive |
| United States | GUDID listing GUDID | Number00844685003921 | Date3 Nov 2016 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- TrabEx EUDAMEDMST/Packard .7mm strt p tp 15° GUDID
- Generic Name
- Phacoemulsification system handpiece tip, reusable
- Model / Ref / Catalog
- 600042 EUDAMEDPT-32315-B-1 GUDID
- Primary DI / UDI-DI
- 00844685003921
- Basic UDI-DI
- B-00844685003921
- 510(k) Number
- FDA Product Code
- HQC
- EMDN Code
- Q02010199 Ophthalmic microknives - other
- GMDN Term
- Phacoemulsification system handpiece tip, reusable
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 886.4670
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 600042 | PT-32315-B-1 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000020475
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from MicroSurgical Technology Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: 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
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No
Sources (2)
- EUDAMED cb38c61f-35de-4121-97f2-ad1d53e3e330
- FDA UDI 6601d540-3542-46e6-b9c3-fe250d1d9641