Duns Number:072943876
Device Description: Drug Free Nasal Strips, Medium, Clear Strips
Catalog Number
-
Brand Name
TopCare health
Version/Model Number
036800118072
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
9ff26686-4208-40a9-92a0-3a02befd9586
Public Version Date
July 21, 2020
Public Version Number
1
DI Record Publish Date
July 13, 2020
Package DI Number
00036800413283
Quantity per Package
36
Contains DI Package
00036800118072
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |