Duns Number:807613393
Device Description: MeroGel Otologic Packing is a space occupying dressing and/or stent intended to separate m MeroGel Otologic Packing is a space occupying dressing and/or stent intended to separate mucosal surfaces, help control minimal bleeding and act as an adjunct to aid in the natural healing process.
Catalog Number
1517100
Brand Name
MeroGel Otologic Packing 1x5cm
Version/Model Number
651-142
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
K001148
Product Code
KHJ
Product Code Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Public Device Record Key
740e44a3-fa54-4883-a87d-3828dc43793a
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 |