Catalog Number

80250-29

Brand Name

OmniTrustTM

Version/Model Number

80250-29

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

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

0059247f-951f-43ab-9c7a-c3a27485f361

Public Version Date

December 24, 2020

Public Version Number

1

DI Record Publish Date

December 16, 2020

Package DI Number

50810572000040

Quantity per Package

8

Contains DI Package

00810572000045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton