Catalog Number

54025

Brand Name

BIOM Optic Set, HD Flex

Version/Model Number

54025

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

-

Product Code

HJL

Product Code Name

Lens, Condensing, Diagnostic

Public Device Record Key

7b0c53df-d467-43fe-9b22-e63e23b65ac4

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

February 15, 2022

Package DI Number

10852475007155

Quantity per Package

12

Contains DI Package

00852475007158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case