Duns Number:051957769
Device Description: Flexible Fabric Bandages, Antibacterial, assorted sizes, 40- 5/8 IN x 2 1/4 IN (15 mm x 5 Flexible Fabric Bandages, Antibacterial, assorted sizes, 40- 5/8 IN x 2 1/4 IN (15 mm x 57 mm), 35- 3/4 IN x 3 IN (19 mm x 76 mm), 25- 1 IN x 3 IN (25 mm x 76 mm)
Catalog Number
-
Brand Name
Equate
Version/Model Number
681131436410
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
cb97af5c-f749-43f6-81ab-2cb6e731d27d
Public Version Date
December 15, 2021
Public Version Number
1
DI Record Publish Date
December 07, 2021
Package DI Number
20681131436414
Quantity per Package
72
Contains DI Package
00681131436410
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |