Polysite - POLYSITE Pressure injectable Implantable Infusion - PEROUSE MEDICAL

Duns Number:267476323

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

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More Product Details

Catalog Number

-

Brand Name

Polysite

Version/Model Number

3017SPI

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 22, 2017

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"

-

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 Details

Product Code

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Record Status

Public Device Record Key

703ba057-952e-4e1a-a463-5f5103b41c3c

Public Version Date

October 23, 2019

Public Version Number

6

DI Record Publish Date

October 20, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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