Catalog Number

-

Brand Name

Cyber Blade

Version/Model Number

20041001

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

K192499,K192499,K192499

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

09aa685b-c98e-49f6-9eed-a51d7fbfd1ab

Public Version Date

February 12, 2021

Public Version Number

1

DI Record Publish Date

February 04, 2021

Package DI Number

18051414960465

Quantity per Package

5

Contains DI Package

08051414960468

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box