Duns Number:008965063
Device Description: Antibacterial Bandage Roll, Polyhexamethylene Biguadine (PHMB) 0.2%, 1 roll, 4.5 IN x 4 YD Antibacterial Bandage Roll, Polyhexamethylene Biguadine (PHMB) 0.2%, 1 roll, 4.5 IN x 4 YD (11.4 cm x 3.6 m)
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
272935
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
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
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
e7f08ef1-10d7-41d2-8051-f5302cef6e52
Public Version Date
December 04, 2020
Public Version Number
1
DI Record Publish Date
November 26, 2020
Package DI Number
20311917219305
Quantity per Package
36
Contains DI Package
00311917219301
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 |