Catalog Number

-

Brand Name

VersaOne

Version/Model Number

RONB11STF

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

K130435,K130435

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

bc99e43d-cf18-4b4f-9b9e-7708d3dccd18

Public Version Date

May 10, 2022

Public Version Number

4

DI Record Publish Date

May 03, 2018

Package DI Number

20884521717685

Quantity per Package

6

Contains DI Package

10884521717688

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK