Duns Number:047741335
Device Description: Drug-Free, Nasal Strips, Clear Medium
Catalog Number
-
Brand Name
Discount Drug Mart Food Fair
Version/Model Number
093351123634
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 04, 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
LWF
Product Code Name
Dilator, Nasal
Public Device Record Key
cb6fce82-012c-433a-8bfe-37d65ee5044a
Public Version Date
August 03, 2022
Public Version Number
2
DI Record Publish Date
August 17, 2020
Package DI Number
20093351123638
Quantity per Package
36
Contains DI Package
00093351123634
Package Discontinue Date
June 04, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |