Polysite - POLYSITE Implantable Infusion Port with - PEROUSE MEDICAL

Duns Number:267476323

Device Description: POLYSITE Implantable Infusion Port with silicone-filled suture holes

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More Product Details

Catalog Number

-

Brand Name

Polysite

Version/Model Number

2016SC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Record Status

Public Device Record Key

1cd08e52-75ba-4922-a3c3-0026e71d15d2

Public Version Date

October 23, 2019

Public Version Number

6

DI Record Publish Date

March 16, 2017

Additional Identifiers

Package DI Number

13661234017567

Quantity per Package

1

Contains DI Package

03661234017560

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PEROUSE MEDICAL" Characteristics
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