Duns Number:063997360
Device Description: Drug Free Nasal Strips; Opens Nasal Passages for Easier Breathing; Relieves Nasal Congesti Drug Free Nasal Strips; Opens Nasal Passages for Easier Breathing; Relieves Nasal Congestion Due to Allergies and Colds; For Sensitive Skin; 30 Clear Medium Strips
Catalog Number
5320536
Brand Name
LEADER
Version/Model Number
5320536
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
f453e778-5d10-4d4d-b52f-91a17206a7b9
Public Version Date
July 02, 2021
Public Version Number
2
DI Record Publish Date
April 18, 2019
Package DI Number
50096295131555
Quantity per Package
36
Contains DI Package
00096295131550
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |