Catalog Number

02-5S-BHL2

Brand Name

Omnia Medical Instruments

Version/Model Number

02-5S-BHL2

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HXB

Product Code Name

Probe

Public Device Record Key

b61b0261-94eb-4160-bc1f-c572aa9c8ed5

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-