Duns Number:267476323
Device Description: POLYSITE Pressure injectable Implantable Infusion Port with silicone-filled suture holes
Catalog Number
-
Brand Name
Polysite
Version/Model Number
2016SPI
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
K122834,K122834
Product Code
LJT
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Public Device Record Key
6e059b1a-f9b8-4c58-9c28-8eceac36fb93
Public Version Date
October 23, 2019
Public Version Number
6
DI Record Publish Date
March 15, 2017
Package DI Number
13661234017543
Quantity per Package
1
Contains DI Package
03661234017546
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 98 |