Catalog Number

A.4522

Brand Name

Rectoscope

Version/Model Number

A.4522

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

K070915,K070915

Product Code

KDM

Product Code Name

Sigmoidoscope, Rigid, Non-Electrical

Public Device Record Key

c3a974ee-6a27-4084-b85e-cf32cdd34817

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 25, 2016

Package DI Number

08033638800270

Quantity per Package

12

Contains DI Package

08033638800263

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-