Duns Number:008965063
Device Description: Walgreens Finger Sleeve w/Gel Insert 2s
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
230820
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"
Yes
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
ILH
Product Code Name
Splint, Hand, And Components
Public Device Record Key
39a67ab8-7f52-4109-a927-1c62bb60d960
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
July 31, 2020
Package DI Number
10311917153442
Quantity per Package
36
Contains DI Package
00311917153445
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 |