Duns Number:298725490
Device Description: Myringotomy Kit with Grommets
Catalog Number
MK72BE32
Brand Name
EXMOOR
Version/Model Number
MK/72/B/E32
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
0f4de8cc-df23-4058-95f3-eb3be0d6b98a
Public Version Date
May 17, 2019
Public Version Number
2
DI Record Publish Date
October 09, 2018
Package DI Number
05060180250621
Quantity per Package
10
Contains DI Package
05060180256784
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 |