Duns Number:008965063
Device Description: WALG TWIST TOP CONTACT LENS CASE
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
SC-206
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
K991206,K991206,K991206
Product Code
LRX
Product Code Name
Case, Contact Lens
Public Device Record Key
0f0c5f80-df47-4126-86cd-c33eb3acafc5
Public Version Date
September 17, 2021
Public Version Number
5
DI Record Publish Date
December 22, 2017
Package DI Number
10311917186792
Quantity per Package
144
Contains DI Package
20311917186799
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 | 75 |
2 | A medical device with a moderate to high risk that requires special controls. | 74 |
U | Unclassified | 2 |