Duns Number:038000253
Device Description: 8F PLASTIC DIGNITY® MID-SIZED CT PORT W/SILCONE FILLED SUTURE HOLES W/ATTACHABLE CHRONOFLE 8F PLASTIC DIGNITY® MID-SIZED CT PORT W/SILCONE FILLED SUTURE HOLES W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER W/5F Micro-Stick® INTRODUCER SET
Catalog Number
MIDP80AMS
Brand Name
DIGNITY®
Version/Model Number
MIDP80AMS
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
d3a98408-33cb-4f07-a644-92f1db5e9851
Public Version Date
November 29, 2019
Public Version Number
1
DI Record Publish Date
November 21, 2019
Package DI Number
50884908149574
Quantity per Package
5
Contains DI Package
00884908149579
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 |