Duns Number:117310689
Device Description: Drug-Free Nasal Strips, Clear Medium
Catalog Number
0900471
Brand Name
Family Wellness
Version/Model Number
032251110443
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"
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
LWF
Product Code Name
Dilator, Nasal
Public Device Record Key
ad123a02-40a9-4edd-8d55-5805dd4299be
Public Version Date
February 02, 2021
Public Version Number
2
DI Record Publish Date
February 28, 2020
Package DI Number
20032251110447
Quantity per Package
36
Contains DI Package
00032251110443
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 |