Catalog Number

0678-001-400

Brand Name

Switchpoint Infinity

Version/Model Number

0678001400

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

K100852

Product Code

OCS

Product Code Name

Endoscopic video imaging system/component, gastroenterology-urology

Public Device Record Key

af82f398-84e4-4b15-86fe-2836c33239b7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-