Catalog Number

33189

Brand Name

TIDI

Version/Model Number

33189

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

ab5d73e4-82f4-49e4-a9bc-e4762a915960

Public Version Date

March 13, 2020

Public Version Number

3

DI Record Publish Date

October 12, 2016

Package DI Number

00618125175499

Quantity per Package

100

Contains DI Package

01618125175498

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-