Duns Number:038000253
Device Description: 6.6F PLASTIC DIGNITY® MID-SIZED CT PORT W/SILICONE FILLED SUTURE HOLES W/ATTACHABLE CHRONO 6.6F PLASTIC DIGNITY® MID-SIZED CT PORT W/SILICONE FILLED SUTURE HOLES W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
Catalog Number
MRDP66AMS
Brand Name
DIGNITY®
Version/Model Number
MRDP66AMS
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
1e67db52-bb02-44d1-9de4-416be287d579
Public Version Date
December 04, 2019
Public Version Number
1
DI Record Publish Date
November 26, 2019
Package DI Number
50884908149857
Quantity per Package
5
Contains DI Package
00884908149852
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 |