Catalog Number

A.4024.1

Brand Name

Anoscope

Version/Model Number

A.4024.1

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

5bc2d6bc-7fd1-4a5b-8a9f-c36d1b5406d9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 25, 2016

Package DI Number

08033638800072

Quantity per Package

50

Contains DI Package

08033638800065

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-