Duns Number:298725490
Device Description: Myringotomy Kit with Grommets
Catalog Number
MK72AE106
Brand Name
EXMOOR
Version/Model Number
MK/72/A/E106
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
-
Product Code
JYP
Product Code Name
Knife, Myringotomy
Public Device Record Key
d0902b67-02a8-453f-8b3f-1f9d2b276d93
Public Version Date
May 10, 2019
Public Version Number
2
DI Record Publish Date
October 08, 2018
Package DI Number
05060180253257
Quantity per Package
10
Contains DI Package
05060180252441
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
a box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 245 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |