Catalog Number

20-30-019-01

Brand Name

HandX

Version/Model Number

20-30-019-01

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

-

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

441008c1-01fc-44ce-9ad7-80526434b0e3

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 06, 2018

Package DI Number

17290017376001

Quantity per Package

2

Contains DI Package

07290017376004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-