Duns Number:092312735
Device Description: Soft Grip Contact Lens Cases
Catalog Number
-
Brand Name
Flents
Version/Model Number
70129
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)
-
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
1f0c8225-115a-4828-a0d6-7d1409106da1
Public Version Date
November 08, 2018
Public Version Number
1
DI Record Publish Date
October 08, 2018
Package DI Number
10023185001140
Quantity per Package
12
Contains DI Package
00023185000276
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
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 |