Catalog Number

490074

Brand Name

Welch Allyn, Inc.

Version/Model Number

901069

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2019

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FSR

Product Code Name

Light, headband, surgical

Public Device Record Key

08911bc9-abda-48f0-b073-7844f01b903c

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-