Duns Number:796263598
Catalog Number
-
Brand Name
EasyFlo Scale
Version/Model Number
84411318
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EXY
Product Code Name
Uroflowmeter
Public Device Record Key
f561099c-6fbc-436c-b89d-0ca566851154
Public Version Date
July 26, 2018
Public Version Number
1
DI Record Publish Date
June 25, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 22 |
3 | A medical device with high risk that requires premarket approval | 7 |