Catalog Number

M8002

Brand Name

VETA Peritoneal Dialysis Catheter

Version/Model Number

M8002

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"

-

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

K113354,K113354,K113354

Product Code

GAH

Product Code Name

Stylet, Surgical, General & Plastic Surgery

Public Device Record Key

54599b93-a89c-48b0-bee9-c95a84039a60

Public Version Date

May 14, 2020

Public Version Number

4

DI Record Publish Date

October 15, 2015

Package DI Number

10813623040523

Quantity per Package

5

Contains DI Package

00813623040526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-