Catalog Number

77791-MX-CL

Brand Name

Welch Allyn, Inc.

Version/Model Number

901027

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 26, 2021

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

K771864

Product Code

GCW

Product Code Name

Transformer, endoscope

Public Device Record Key

ffa6d1f4-5dfb-49d8-bbdc-5494eeefa209

Public Version Date

January 27, 2021

Public Version Number

2

DI Record Publish Date

June 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-