Duns Number:152793493
Device Description: Nasal Strips, Extra Strength, Black Strips
Catalog Number
-
Brand Name
Clear Passage Nasal Strips
Version/Model Number
017276238877
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
db0df515-4189-41ad-b05b-39e54b810245
Public Version Date
July 13, 2022
Public Version Number
1
DI Record Publish Date
July 05, 2022
Package DI Number
20017276238871
Quantity per Package
48
Contains DI Package
00017276238877
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 | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |