Duns Number:008965063
Device Description: Elastic Tape, 2 IN X 2.5 YD (50 mm x 2.28 m) unstretched
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
109893
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
acd0e872-6d96-48bf-9b38-a39e99dd1ac8
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 27, 2020
Package DI Number
10311917205479
Quantity per Package
24
Contains DI Package
00311917205472
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 |