Duns Number:038000253
Device Description: 5F PLASTIC DIGNITY® LOW PROFILE CT PORT W/SILICONE FILLED SUTURE HOLES W/PRE-ATTACHED Chro 5F PLASTIC DIGNITY® LOW PROFILE CT PORT W/SILICONE FILLED SUTURE HOLES W/PRE-ATTACHED ChronoFlex® POLYURETHANE CATHETER
Catalog Number
MRDP50PLS
Brand Name
DIGNITY®
Version/Model Number
MRDP50PLS
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"
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
-
Product Code
LJT
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Public Device Record Key
6e94dc55-3513-4240-b5ca-54c81a5ac37c
Public Version Date
December 06, 2019
Public Version Number
1
DI Record Publish Date
November 28, 2019
Package DI Number
50884908149772
Quantity per Package
5
Contains DI Package
00884908149777
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |