Duns Number:117310689
Device Description: Non-Stick Pads, all one size, 3 IN x 4 IN (76 mm x 101 mm)
Catalog Number
0903221
Brand Name
Family Wellness
Version/Model Number
032251057847
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 16, 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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
f3f21578-3800-4de2-ba73-8546309730a7
Public Version Date
August 24, 2021
Public Version Number
4
DI Record Publish Date
February 28, 2020
Package DI Number
20032251057841
Quantity per Package
72
Contains DI Package
00032251057847
Package Discontinue Date
March 16, 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 |