Duns Number:298725490
Device Description: Myringotomy Kit
Catalog Number
MK/82/B/GR/2
Brand Name
EXMOOR
Version/Model Number
MK/82/B/GR/2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2019
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
fd5a99cf-7eb6-460d-bb5e-1d39d43fbb75
Public Version Date
May 06, 2019
Public Version Number
2
DI Record Publish Date
September 19, 2018
Package DI Number
05060180253882
Quantity per Package
10
Contains DI Package
05060180257361
Package Discontinue Date
May 01, 2019
Package Status
Not 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 |