Catalog Number

3034A

Brand Name

FLX-LITE

Version/Model Number

3034A

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

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

KYT

Product Code Name

LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED

Public Device Record Key

5c6b3b85-a997-4c80-960d-426adc3e8e1b

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

20845854044343

Quantity per Package

3

Contains DI Package

10845854044346

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX