Duns Number:088528245
Device Description: Unna Boot CalamineA single roll of soft foam impregnated with calamine.PK SINGLE Roll 4" X Unna Boot CalamineA single roll of soft foam impregnated with calamine.PK SINGLE Roll 4" X 6 Yds
Catalog Number
UB840C-01
Brand Name
UBC
Version/Model Number
PK SINGLE Roll 4" X 6 Yds
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
3455912e-d762-4abb-84dc-6718b2d4d7ff
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 05, 2022
Package DI Number
00724004613652
Quantity per Package
12
Contains DI Package
10724004613659
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 | 55 |