Catalog Number

OTDB

Brand Name

OmniSight™

Version/Model Number

OTDB

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K010548,K010548

Product Code

MMP

Product Code Name

Cover, barrier, protective

Public Device Record Key

81191099-2c3e-4d15-9ca2-cd877a8f5798

Public Version Date

October 26, 2022

Public Version Number

6

DI Record Publish Date

August 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-