Identity
- Trade Name
- Wrench, Helical Drive, ML7 FDA UDI
- Generic Name
- Microkeratome FDA UDI
- Device Name
- ML7 Helical Drive Wrench EUDAMEDWrench use to adjust helical screw on the ML7 Vacuum Rings FDA UDI
- Model / Reference
- 1350ML7 EUDAMEDFDA UDI
- Description
- Wrench use to adjust helical screw on the ML7 Vacuum Rings FDA UDI
Identifiers
- Catalog Number
- 1350ML7 FDA UDI
- Primary DI / UDI-DI
- 00850011743997 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850011743997 EUDAMED
- FDA Product Code
- HNO FDA UDI
- EMDN Code
- Z1212020580 MICROKERATOMY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Microkeratome FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4370 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
ML7 Helical Drive Wrench by Med Logics Inc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850011743997 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Med-Logics, Inc.
- EUDAMED SRN
- US-MF-000004600
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED 58ce3b60-57d2-4847-b968-f86e77656476 61 fields · synced Jun 19, 2026
- FDA UDI 9c0c220b-adb1-4100-b46e-f7ade638299d 35 fields · synced May 30, 2026