Duns Number:008965063
Device Description: Walgreens Twist Top Contact Lens Case 6 ct
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
104461
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
272ccf8e-80d8-4075-903d-826e8f09bcee
Public Version Date
October 29, 2021
Public Version Number
1
DI Record Publish Date
October 21, 2021
Package DI Number
10311917011292
Quantity per Package
128
Contains DI Package
00311917011295
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 |