Duns Number:966806150
Device Description: METRON CLEAR ULTRASOUND GEL, 5L
Catalog Number
922099
Brand Name
METRON
Version/Model Number
922099
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MUI
Product Code Name
Media,Coupling,Ultrasound
Public Device Record Key
7ab4f5ed-bd0f-4df0-865b-d1ff380c0298
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
10885914022020
Quantity per Package
4
Contains DI Package
00885914022023
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |