Duns Number:038000253
Device Description: 5F PLASTIC DIGNITY® LOW PROFILE CT PORT W/SILICONE FILLED SUTURE HOLES W/ATTACHABLE Chrono 5F PLASTIC DIGNITY® LOW PROFILE CT PORT W/SILICONE FILLED SUTURE HOLES W/ATTACHABLE ChronoFlex® POLYURETHANE CATHETER
Catalog Number
MRDP50ALS
Brand Name
DIGNITY®
Version/Model Number
MRDP50ALS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 03, 2020
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
3ab70698-d6aa-4e89-8ca1-52a302fb48a0
Public Version Date
October 06, 2020
Public Version Number
2
DI Record Publish Date
November 28, 2019
Package DI Number
50884908149710
Quantity per Package
5
Contains DI Package
00884908149715
Package Discontinue Date
August 03, 2020
Package Status
Not 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 |