Ophthalmic Knives
by Alcon Laboratories, Inc. United States EUDAMEDGUDID
Ref 681.26
Product code HNNEMDN Q02010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number038065GMN000159HH | Date8 Jan 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07612717000193 | Date19 Aug 2020 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Alcon Grieshaber
- Generic Name
- Ophthalmic knife, reusable
- Device Name
- Ophthalmic Knives
- Model / Reference
- 681.26
- Primary DI / UDI-DI
- 07612717000193
- Basic UDI-DI
- 038065GMN000159HH
- Direct Marketing DI
- 07612717000193
- FDA Product Code
- HNN
- EMDN Code
- Q02010101 Ophthalmic microknives, straight
- GMDN Term
- Ophthalmic knife, reusable
- Device Class
- Class I
- Regulation Number
- 886.4350
- Market of Registration
- Belgium
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Radiation Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Sterile | Yes | No |
Manufacturer details
- EUDAMED SRN
- US-MF-000016248
- Authorised representative
- Alcon Laboratories Belgium BE-AR-000014721
Other devices from Alcon Laboratories, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (17)
- Single Use: No
- Implantable: 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
Sources (2)
- EUDAMED f688aa63-4412-4b75-bfe4-141be30ba29a
- FDA UDI 2e639537-1128-4718-8dd0-dc912b3228e8