Catalog Number

-

Brand Name

Video Adapter

Version/Model Number

OLYMPUS AR-T12E

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

K002231

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

4f7010d8-0b13-43ac-a5b5-ddf0822e4271

Public Version Date

September 05, 2022

Public Version Number

7

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-