Catalog Number

20-30-009-01

Brand Name

HandX Disposables

Version/Model Number

20-30-008-01

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

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

d356d5a7-06d6-45c9-91d0-0989268c7d8a

Public Version Date

January 26, 2022

Public Version Number

2

DI Record Publish Date

September 06, 2018

Package DI Number

17290017376032

Quantity per Package

6

Contains DI Package

07290017376035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-