Catalog Number

-

Brand Name

VersaOne

Version/Model Number

UNVCA5STF

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

K112349,K112349

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

b3c6a685-8f07-45ef-b1cd-b9954165f5ee

Public Version Date

May 23, 2022

Public Version Number

4

DI Record Publish Date

September 25, 2016

Package DI Number

40884521215420

Quantity per Package

6

Contains DI Package

30884521215423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX