Duns Number:058716649
Device Description: ASSY, TBG, PRES 50, MC (86990679)
Catalog Number
PRES50
Brand Name
MEDRAD® PRES
Version/Model Number
PRES50
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
K083723,K083723
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
fe002289-882e-4a52-b556-a1c4adcf5cd8
Public Version Date
April 29, 2021
Public Version Number
1
DI Record Publish Date
April 21, 2021
Package DI Number
40616258022633
Quantity per Package
50
Contains DI Package
00616258022635
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 |