Identity
- Trade Name
- Amoils Epithelial Scrubber FDA UDI
- Generic Name
- Corneal bur system, battery-powered FDA UDI
- Device Name
- Amoils Epithelial Scrubber - Hyperopic Pack of 25 FDA UDI
- Model / Reference
- Hyperopic Pack of 25 FDA UDI
- Description
- Amoils Epithelial Scrubber - Hyperopic Pack of 25 FDA UDI
Identifiers
- Catalog Number
- AM1EX-HYPx FDA UDI
- Primary DI / UDI-DI
- 00628693343046 FDA UDI
- 510(k) Number
- K962989 FDA UDI
- FDA Product Code
- HOG FDA UDI
- GMDN Term
- Corneal bur system, battery-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4070 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
Yes
FDA UDI
Category: Corneal bur system, battery-powered
Amoils Epithelial Scrubber by Innova Medical Ophthalmics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K962989 also covers:
- Amoils Epithelial Scrubber — Innova Medical Ophthalmics Inc
- Amoils Epithelial Scrubber — Innova Medical Ophthalmics Inc
- Amoils Epithelial Scrubber — Innova Medical Ophthalmics Inc
- Amoils Epithelial Scrubber — Innova Medical Ophthalmics Inc
- Amoils Epithelial Scrubber — Innova Medical Ophthalmics Inc
- Amoils Epithelial Scrubber — Innova Medical Ophthalmics Inc
- Amoils Epithelial Scrubber — Innova Medical Ophthalmics Inc
- Amoils Epithelial Scrubber — Innova Medical Ophthalmics Inc
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 |
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Manufacturer
- Manufacturer
- Innova Medical Ophthalmics Inc
Sources (1)
- FDA UDI 80dee940-d9f4-43b8-8c95-58f18ce51707 35 fields · synced May 30, 2026