Duns Number:080361159
Device Description: CONTACT LENS CASE SCREW TOP
Catalog Number
-
Brand Name
ASP MEDICAL
Version/Model Number
70685
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
a685bad7-e2d9-44b5-8c73-dd030dfe4be8
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 26, 2020
Package DI Number
10840216101637
Quantity per Package
100
Contains DI Package
00840216101630
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1046 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |
U | Unclassified | 2 |