Duns Number:038000253
Device Description: 8F PLASTIC DIGNITY® MINI PROFILE CT PORT W/SILCONE FILLED SUTURE HOLES W/ATTACHABLE Chrono 8F PLASTIC DIGNITY® MINI PROFILE CT PORT W/SILCONE FILLED SUTURE HOLES W/ATTACHABLE ChronoFlex® POLYURETHANE CATHETER W/5F Micro-Stick® INTRODUCER SET
Catalog Number
MIDP80AXS
Brand Name
DIGNITY®
Version/Model Number
MIDP80AXS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 04, 2021
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
774282d7-4095-4729-90cd-549e28598c4e
Public Version Date
October 08, 2021
Public Version Number
2
DI Record Publish Date
November 21, 2019
Package DI Number
50884908149598
Quantity per Package
5
Contains DI Package
00884908149593
Package Discontinue Date
October 04, 2021
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 |