Duns Number:058716649
Device Description: Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a female-to-female adaptor) for pre-filled syringes (SET,PKG,INTEG T/CV,MRI SIT96V,RAD,MC,JA2) (85233106)
Catalog Number
SIT 96V
Brand Name
MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector
Version/Model Number
SIT 96V
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"
Yes
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
K980417,K980417
Product Code
LNH
Product Code Name
System, Nuclear Magnetic Resonance Imaging
Public Device Record Key
448c5c4b-2cc8-4044-a7e9-626402b4b006
Public Version Date
May 28, 2019
Public Version Number
1
DI Record Publish Date
May 20, 2019
Package DI Number
40616258010005
Quantity per Package
50
Contains DI Package
00616258010007
Package Discontinue Date
December 31, 9999
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 360 |