Ophthalmic Forceps Instruments DSP
by Alcon Laboratories, Inc. EUDAMEDGUDID
Active
Ref 705.44
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number038065GMN000160H2 | Date8 Jan 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07612717064263 | Date18 Aug 2020 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- Alcon Grieshaber REVOLUTION
- Generic Name
- Ophthalmic soft-tissue manipulation forceps, probe-like, single-use
- Device Name
- Ophthalmic Forceps Instruments DSP
- Model / Reference
- 705.44
- Primary DI / UDI-DI
- 07612717064263
- Basic UDI-DI
- 038065GMN000160H2
- FDA Product Code
- HNR
- EMDN Code
- Q021102 Ophthalmic surgery forceps, single-use
- GMDN Term
- Ophthalmic soft-tissue manipulation forceps, probe-like, single-use
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 886.4350
- Market of Registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000016248
- Authorised representative
- Alcon Laboratories Belgium BE-AR-000014721
Other devices from Alcon Laboratories, Inc.
Properties
Other properties (16)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: 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