Identity
- Trade Name
- ML7040 (Plus 20) FDA UDI
- Generic Name
- Keratome blade, single-use FDA UDI
- Device Name
- Sterile Disposable microkeratome blade, for use on the Alcon SKBM Microkeratome FDA UDI
- Model / Reference
- ML7040 (+20) FDA UDI
- Description
- Sterile Disposable microkeratome blade, for use on the Alcon SKBM Microkeratome FDA UDI
Identifiers
- Catalog Number
- ML7040 (+20) FDA UDI
- Primary DI / UDI-DI
- 00850724001247 FDA UDI
- 510(k) Number
- K002515 FDA UDI
- FDA Product Code
- HNO FDA UDI
- GMDN Term
- Keratome blade, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Keratome blade, single-use
ML7040 (Plus 20) by Med Logics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Keratome blade, single-use.
- SURGISTAR — Surgistar Inc. · Class I
- SURGISTAR — Surgistar Inc. · Class I
- SURGISTAR — Surgistar Inc. · Class I
- SURGISTAR — Surgistar Inc. · Class I
- AMADEUS — SIS AG, Surgical Instrument Systems · Class I
- SURGISTAR — Surgistar Inc. · Class I
- ML7040 (Minus 20) — MED LOGICS INC · Class I
- ML7040 (Plano) — MED LOGICS INC · Class I
Cleared under the same submission
K002515 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Med Logics Inc
Sources (1)
- FDA UDI d4f12ff8-15df-4cfc-9aef-d5adb1204625 36 fields · synced Jun 8, 2026