Duns Number:458942687
Device Description: SC760 MRI Suction controller kit.High suction, with forward facingmounting system and 2 m SC760 MRI Suction controller kit.High suction, with forward facingmounting system and 2 m hose
Catalog Number
-
Brand Name
SC760 MRI Suction Controller 2m hose
Version/Model Number
SC760 MRI
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
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
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
f4ca2e9e-a012-4e8b-ab9d-40918f0d3215
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 01, 2017
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 37 |