Catalog Number

50-9210

Brand Name

PeritX

Version/Model Number

50-9210

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

PNG

Product Code Name

Peritoneal, drainage catheter for refractory ascites, long-term indwelling

Public Device Record Key

34c1c846-dc29-4fc0-8631-e22f28d4c477

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

June 12, 2017

Package DI Number

50885403222724

Quantity per Package

5

Contains DI Package

10885403222726

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case