Catalog Number

380067-501

Brand Name

Welch Allyn, Inc.

Version/Model Number

901117

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K810227

Product Code

FER

Product Code Name

Anoscope and accessories

Public Device Record Key

94f10200-e923-4c9f-b135-f52643c352d1

Public Version Date

October 09, 2019

Public Version Number

1

DI Record Publish Date

October 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-