Catalog Number

-

Brand Name

VersaStep

Version/Model Number

VS101500

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

K012539,K012539

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

c78342e6-8df7-4b23-8066-cfa00a38a5a6

Public Version Date

July 05, 2022

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

10884521084155

Quantity per Package

6

Contains DI Package

20884521084152

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE