Catalog Number

-

Brand Name

ClearCap Distal Attachment

Version/Model Number

FM-EC0001

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

K202616,K202616,K202616

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

71011f68-1ca7-4f40-b054-247a27544574

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

March 11, 2021

Package DI Number

18809327352804

Quantity per Package

10

Contains DI Package

08809327352807

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box