Duns Number:933509465
Device Description: Fabric Bandages, assorted sizes, 5- 3 in x 1 in (76 mm x 25 mm), 10- 3 in x 3/4 in (76 m Fabric Bandages, assorted sizes, 5- 3 in x 1 in (76 mm x 25 mm), 10- 3 in x 3/4 in (76 mm x 19 mm), 10- 2 1/4 in x 5/8 in (57 mm x 15 mm)
Catalog Number
-
Brand Name
ALL TERRAIN
Version/Model Number
608503050036
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
41c6523e-c133-47a7-b354-ae7bd6527d33
Public Version Date
December 24, 2020
Public Version Number
1
DI Record Publish Date
December 16, 2020
Package DI Number
10608503050033
Quantity per Package
72
Contains DI Package
00608503050036
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 | 2 |