Duns Number:051957769
Device Description: Heavy Duty Fabric Bandages,Antibacterial, all one size, X-Large, 1 3/4 IN x 4 IN (44 mm x Heavy Duty Fabric Bandages,Antibacterial, all one size, X-Large, 1 3/4 IN x 4 IN (44 mm x 101 mm)
Catalog Number
-
Brand Name
Equate
Version/Model Number
681131006743
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
58b3b6d6-4381-4500-8fb7-6b07b7b9f98a
Public Version Date
September 28, 2020
Public Version Number
1
DI Record Publish Date
September 20, 2020
Package DI Number
20681131006747
Quantity per Package
72
Contains DI Package
00681131006743
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 |