Catalog Number

83-20-5003

Brand Name

OMNI

Version/Model Number

83-20-5003

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

-

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

FST

Product Code Name

Light, Surgical, Fiberoptic

Public Device Record Key

d8f6abef-79b4-4147-ac73-17611e3438d6

Public Version Date

September 25, 2020

Public Version Number

1

DI Record Publish Date

September 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-