Catalog Number

PV-SLMK-001

Brand Name

Pure-Vu

Version/Model Number

PV-SLMK-001

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

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

K160015,K160015

Product Code

FDF

Product Code Name

Colonoscope And Accessories, Flexible/Rigid

Public Device Record Key

d94b0e74-0277-472e-b364-42c3dc5db1db

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 26, 2018

Package DI Number

05060513700113

Quantity per Package

5

Contains DI Package

05060513700106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 small boxes in 1