Catalog Number

-

Brand Name

VersaOne

Version/Model Number

NONB5LGF

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

K151548,K151548

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

4ddbe209-2229-4568-bb96-ea7876c3fa56

Public Version Date

February 18, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884521546865

Quantity per Package

6

Contains DI Package

10884521546868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK