Duns Number:006426316
Device Description: NASAL PLUGS (COTTON), 300EA
Catalog Number
191221
Brand Name
Mueller Nasal Plugs
Version/Model Number
191221
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"
-
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
LYA
Product Code Name
SPLINT, INTRANASAL SEPTAL
Public Device Record Key
073e199d-34d2-4dbb-89ed-d91dedd6f287
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 148 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |