FDA UDI
In Commercial Distribution
🇺🇸 United States
MYAH
DI: 08034028770487
·
Model: MYAH
·
VISIA IMAGING SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MYAH
- Primary DI
- 08034028770487
- Version / Model
- MYAH
- Catalog Number
- 42-0000983US
- Company Name
- VISIA IMAGING SRL
- Labeler DUNS
- 447668039
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-12
- Public Version
- 1
- Public Version Date
- 2023-10-20
- Public Version Status
- New
- Public Device Record Key
- 3cba00ab-c01c-40f5-9cfc-fc663f75c8ac
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MXK | Device, Analysis, Anterior Segment | Ophthalmic | 886.1850 | 2 |
| HKI | Camera, Ophthalmic, Ac-Powered | Ophthalmic | 886.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18038 | Corneal topography system | An assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface. It typically consists of a line-powered videokeratoscope using Placido imaging (involves disk with concentric white and black rings), and application software for installation in an included computer workstation, or external computer, for image processing and analysis. This device will be used to evaluate the need for refractive eye surgery, e.g., laser assisted in situ keratomileusis (LASIK) treatment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08034028770487 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222933 | 000 |