Catalog Number

A.4019

Brand Name

Anoscope

Version/Model Number

A.4019

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"

Yes

For Single-Use

Yes

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

K070913,K070913

Product Code

FER

Product Code Name

Anoscope And Accessories

Public Device Record Key

3b817d38-2a9d-44cb-b059-05398ce11741

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 25, 2016

Package DI Number

08033638800034

Quantity per Package

75

Contains DI Package

08033638800027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-