Catalog Number

-

Brand Name

BluView

Version/Model Number

BV-5X100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 31, 2019

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

089d643f-e300-41a5-83e5-c9ab08d4724a

Public Version Date

February 17, 2020

Public Version Number

5

DI Record Publish Date

April 10, 2019

Package DI Number

20412786063232

Quantity per Package

12

Contains DI Package

10412786063235

Package Discontinue Date

October 31, 2019

Package Status

Not in Commercial Distribution

Package Type

CARTON