Duns Number:117310689
Device Description: Value Pack Assorted Bandages, Assorted sizes, XL Fabric 2 in x 4 in (50 mm x 101 mm); Fabr Value Pack Assorted Bandages, Assorted sizes, XL Fabric 2 in x 4 in (50 mm x 101 mm); Fabric 3/4 in x 3 in (19 mm x 76 mm); Tie Dye 3/4 in x 3 in (19 mm x 76 mm); Strong Strip 1 in x 3 1/4 in (25 mm x 82 mm); Foam 5/8 in x 2 1/4 in (15 mm x 57 mm); Waterproof 1 in x 2 1/2 in (25 mm x 63 mm); Waterproof 3/4 in x 2 in (19 mm x 50 mm)
Catalog Number
-
Brand Name
Family Wellness
Version/Model Number
0999413
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
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
2465f80a-6d8b-415c-8851-d3c6950aaa6b
Public Version Date
February 15, 2021
Public Version Number
1
DI Record Publish Date
February 05, 2021
Package DI Number
20032251479773
Quantity per Package
72
Contains DI Package
00032251479779
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |