Duns Number:058716649
Device Description: Spectris MR KIT,SYR/SPIKE/T,65ML FLS,MRI,BURRON and FFA 50(MR - SPECTRIS SYRINGE KIT, 2-65 Spectris MR KIT,SYR/SPIKE/T,65ML FLS,MRI,BURRON and FFA 50(MR - SPECTRIS SYRINGE KIT, 2-65ML, FFA50)(60728524)
Catalog Number
SQK 65VA
Brand Name
Disposable MRI Kit with Check Valve
Version/Model Number
SQK 65VA
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
46a132d2-c5af-45db-8bb6-f0b61a883b6e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10616258005475
Quantity per Package
50
Contains DI Package
00616258005478
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 |