Duns Number:807613393
Device Description: MEROGEL Injectable is a bioresorbable nasal dressing and sinus stent and otologic gel desi MEROGEL Injectable is a bioresorbable nasal dressing and sinus stent and otologic gel designed to help control bleeding and to create a physical separation of mucosal surfaces with the purpose of preventing adhesions during the post-operative healing process
Catalog Number
CFN 1518000
Brand Name
Merogel Injectable
Version/Model Number
640-023
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122434
Product Code
NHB
Product Code Name
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Public Device Record Key
211290da-2043-41f7-a5ab-13941590b28a
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
September 24, 2016
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| 3 | A medical device with high risk that requires premarket approval | 15 |