Duns Number:961027315
Device Description: REPLACEMENT LENS CARDINAL HEALTH FOR CAH FRAME DISPOSABLE
Catalog Number
CAHLENS
Brand Name
CARDINAL HEALTH & Design
Version/Model Number
CAHLENS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HOY
Product Code Name
Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
Public Device Record Key
39b39aad-5bbc-4b7f-8142-c4c2769aafa4
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
May 25, 2018
Package DI Number
50885380070608
Quantity per Package
6
Contains DI Package
20885380070607
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |