Duns Number:092312735
Device Description: CONTACT LENS CASE
Catalog Number
-
Brand Name
CDC
Version/Model Number
C283CD1
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
-
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
LRX
Product Code Name
Case, Contact Lens
Public Device Record Key
0f13f596-1a14-49b9-8bb7-ca31e02e791e
Public Version Date
May 08, 2019
Public Version Number
3
DI Record Publish Date
March 06, 2017
Package DI Number
10840986015882
Quantity per Package
6
Contains DI Package
20840986015889
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 | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 10 |