Duns Number:006961700
Device Description: Clear Nasal Strips, small/medium size
Catalog Number
-
Brand Name
Up&Up
Version/Model Number
094010238
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 26, 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
70da7a40-0d12-44c6-bdd9-0b039e0f2237
Public Version Date
September 29, 2021
Public Version Number
2
DI Record Publish Date
February 28, 2020
Package DI Number
10017276234920
Quantity per Package
36
Contains DI Package
00017276234923
Package Discontinue Date
February 26, 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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |
| U | Unclassified | 12 |