Catalog Number

-

Brand Name

Typenex Wound Drainage

Version/Model Number

WD1009

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

GBX

Product Code Name

Catheter, Irrigation

Public Device Record Key

7a52e851-88b7-40ee-b032-80050d1b93f0

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

August 13, 2021

Package DI Number

10810050853733

Quantity per Package

20

Contains DI Package

00810050853736

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case