Catalog Number

5460-700-037

Brand Name

NA

Version/Model Number

5460-700-037

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 12, 2028

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HPP

Product Code Name

Headlamp, Operating, Battery-Operated

Public Device Record Key

0a97eb1c-5977-4a58-8acd-7da8c54c3310

Public Version Date

March 03, 2021

Public Version Number

6

DI Record Publish Date

January 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-