Catalog Number

-

Brand Name

BluView

Version/Model Number

BV-12X70

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

b6ae69dd-9c6a-46a5-bb6a-f0879a3322f0

Public Version Date

April 20, 2021

Public Version Number

1

DI Record Publish Date

April 12, 2021

Package DI Number

14714127860012

Quantity per Package

5

Contains DI Package

04714127860015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box