Duns Number:117310689
Device Description: Waterproof Adhesive Tape, 1/2 IN x 5 YDS (12.7 mm x 4.5 m)
Catalog Number
0910862
Brand Name
Family Wellness
Version/Model Number
032251058141
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 07, 2021
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
6a55e72d-271f-44f1-ab11-4fa3874ade84
Public Version Date
August 23, 2021
Public Version Number
3
DI Record Publish Date
February 28, 2020
Package DI Number
20032251058145
Quantity per Package
72
Contains DI Package
00032251058141
Package Discontinue Date
January 07, 2021
Package Status
Not 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 |