Duns Number:343189676
Device Description: PROSA WITH PED.PRECHAMBER
Catalog Number
FV741T
Brand Name
proSA®
Version/Model Number
FV741T
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 08, 2020
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
0b6257ee-4ce7-4861-b8a7-899447f72828
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
November 11, 2015
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. | 630 |