Duns Number:117310689
Device Description: Tender Tape, 2 in x 2.3 yds (50 mm x 2.1 m) unstretched
Catalog Number
-
Brand Name
Family Wellness
Version/Model Number
0908830
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 07, 2022
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
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
d96af94c-6e77-4111-bdd3-6cb92e990dc2
Public Version Date
January 07, 2022
Public Version Number
4
DI Record Publish Date
February 05, 2021
Package DI Number
20032251057520
Quantity per Package
72
Contains DI Package
00032251057526
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 |