Catalog Number

410175

Brand Name

Welch Allyn, Inc.

Version/Model Number

901071

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

HIB

Product Code Name

Speculum, vaginal, nonmetal

Public Device Record Key

fa1bf2a2-f326-4914-b33e-0af9ee5ada7f

Public Version Date

September 24, 2019

Public Version Number

3

DI Record Publish Date

December 05, 2017

Package DI Number

00732094202700

Quantity per Package

24

Contains DI Package

00732094214185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-