Catalog Number

-

Brand Name

BluView

Version/Model Number

BV-12X100

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

-

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

e1c3fffb-90b9-4ae9-ac30-ad38470e57fc

Public Version Date

January 09, 2020

Public Version Number

2

DI Record Publish Date

December 17, 2019

Package DI Number

24714127860804

Quantity per Package

12

Contains DI Package

14714127860807

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton