Duns Number:807613393
Device Description: Medtronic MeroGel Nasal Dressing/Sinus stent and Otologic Packing is used in the nasal/sin Medtronic MeroGel Nasal Dressing/Sinus stent and Otologic Packing is used in the nasal/sinus and the middle ear/external ear canal as a space occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery, and in otologic packing, to act as an adjunct to aid in the natural healing process.
Catalog Number
1517002
Brand Name
Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm
Version/Model Number
651-141
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
K982731
Product Code
EMX
Product Code Name
Balloon, Epistaxis
Public Device Record Key
397d215a-1fee-41f5-b735-cb57799e5b3b
Public Version Date
December 21, 2020
Public Version Number
5
DI Record Publish Date
February 19, 2018
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 |