Duns Number:058716649
Device Description: "MR Female to Female Adapter(KIT,ADAPTER,FEMALE-FEMALE LUER,MRI,MC,JA)(84194921)"
Catalog Number
FFA 50
Brand Name
Female - Female Adapter
Version/Model Number
FFA 50
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
e8f0df88-1257-4d78-b945-0c978c1e03cf
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10616258007271
Quantity per Package
50
Contains DI Package
00616258007274
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 |