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
Not in Commercial Distribution
Commercial Distribution End Date
March 22, 2017
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122834
Product Code
LJT
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Public Device Record Key
e35fb44f-7450-44e4-b671-4ae866d4d845
Public Version Date
October 23, 2019
Public Version Number
6
DI Record Publish Date
October 20, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |