FDA UDI
In Commercial Distribution
🇺🇸 United States
Atlas
DI: 05070000542829
·
Model: Global
·
Eyoto, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Atlas
- Primary DI
- 05070000542829
- Version / Model
- Global
- Catalog Number
- 3-004-0003-01
- Company Name
- Eyoto, Inc.
- Labeler DUNS
- 037667526
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-17
- Public Version
- 1
- Public Version Date
- 2022-11-25
- Public Version Status
- New
- Public Device Record Key
- 18e6b827-0564-4ecb-962e-875c9721c1ad
Device Description
Automated AC powered Ophthalmic Lens Analyser for use in the testing and verification of semi finished and finished unmounted ophthalmic lenses
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| HLM | Instrument, Measuring, Lens, Ac-Powered | Ophthalmic | 886.1425 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45753 | Automated lensmeter | A mains electricity (AC-powered) ophthalmic instrument designed to measure the focusing power (dioptric power) and other optical characteristics of a spectacle lens, contact lens, or prism. The device is fully automated and does not require manual adjustments of its measurement systems. It provides the operator with automatic readings on an integral screen, and will typically record and print-out the results. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05070000542829 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 800 – 1060 millibar