FDA UDI
In Commercial Distribution
🇺🇸 United States
Amoils Epithelial Scrubber
DI: 00628693343046
·
Model: Hyperopic Pack of 25
·
Innova Medical Ophthalmics Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Amoils Epithelial Scrubber
- Primary DI
- 00628693343046
- Version / Model
- Hyperopic Pack of 25
- Catalog Number
- AM1EX-HYPx
- Company Name
- Innova Medical Ophthalmics Inc
- Labeler DUNS
- 249464702
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 1
- Public Version Date
- 2022-12-09
- Public Version Status
- New
- Public Device Record Key
- 80dee940-d9f4-43b8-8c95-58f18ce51707
Device Description
Amoils Epithelial Scrubber - Hyperopic Pack of 25
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HOG | Burr, Corneal, Battery-Powered | Ophthalmic | 886.4070 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42443 | Corneal bur system, battery-powered | An assembly of devices designed for abrasion of the cornea and other eye tissues. It typically consists of a small, battery-powered rotatory handpiece with a motor, and a small shaft made of a hard metal such as steel (i.e., a bur) that may include a diamond sphere at its tip. The system is used in procedures such as the gentle removal ("brushing") of rust stains (rust rings) from the cornea after the extraction of a ferrous foreign object, abrasion of the cornea to polish corneal scratches or the pterygium bed after surgical removal, and/or abrasion of lid margin lesions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628693343046 | GS1 | ||||
| Unit of Use | 00628693343015 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K962989 | 000 |