Duns Number:062312574
Device Description: Extra Strength Nasal Strips, Tan Strips
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
209391
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
9c5e4a6e-a5c6-4674-abe3-3f4f069b6386
Public Version Date
September 15, 2020
Public Version Number
1
DI Record Publish Date
September 07, 2020
Package DI Number
20050428583115
Quantity per Package
48
Contains DI Package
00050428583111
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |