Catalog Number

-

Brand Name

VersaOne

Version/Model Number

FCSPASS

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

K163654

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

dd790b1b-70ba-4f7d-ae40-556029dee6a1

Public Version Date

April 18, 2022

Public Version Number

4

DI Record Publish Date

April 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-