Catalog Number

-

Brand Name

Tiger Medical Products

Version/Model Number

ORT400-BULK

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

a4151578-18c1-43b8-8cd0-3180375dfe2f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 01, 2016

Package DI Number

10840216101453

Quantity per Package

400

Contains DI Package

00840216101456

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bale