Duns Number:362747011
Device Description: The ZEISS ATLAS Corneal Topography System is intended to measure and analyze thecorneal cu The ZEISS ATLAS Corneal Topography System is intended to measure and analyze thecorneal curvature of the eye.
Catalog Number
-
Brand Name
ATLAS Corneal Topography System
Version/Model Number
9000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 13, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HJB
Product Code Name
Instrument, Measuring, Corneal Radius
Public Device Record Key
f63ad62f-68b5-4002-b5a4-1cf3055ff848
Public Version Date
July 16, 2018
Public Version Number
1
DI Record Publish Date
June 13, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |