Catalog Number

328044-502

Brand Name

Welch Allyn, Inc.

Version/Model Number

901017

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FER

Product Code Name

Anoscope and accessories

Public Device Record Key

2b768162-9fcf-4e2c-bad9-730ce1caabb6

Public Version Date

June 27, 2022

Public Version Number

2

DI Record Publish Date

April 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-