Catalog Number

30950169

Brand Name

Kendall

Version/Model Number

30950169

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FSD

Product Code Name

BINDER, ABDOMINAL

Public Device Record Key

2f38ef6d-2215-424c-b223-3049b2004033

Public Version Date

October 07, 2019

Public Version Number

3

DI Record Publish Date

June 23, 2018

Package DI Number

10884527005345

Quantity per Package

100

Contains DI Package

20884527005342

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE