Duns Number:117310689
Device Description: Bandage Roll, all one size, 4.5 IN x 4 YDS stretched (114 mm x 3.6 m)
Catalog Number
0908824
Brand Name
Family Wellness
Version/Model Number
032251057465
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 15, 2020
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
NAB
Product Code Name
Gauze / Sponge,Nonresorbable For External Use
Public Device Record Key
2e044166-73a2-4486-9541-91cdae4335bf
Public Version Date
August 24, 2021
Public Version Number
4
DI Record Publish Date
February 28, 2020
Package DI Number
20032251057469
Quantity per Package
36
Contains DI Package
00032251057465
Package Discontinue Date
December 15, 2020
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 |