Catalog Number

-

Brand Name

Acculite EndoOto

Version/Model Number

Gherini, 24ga Str, SmartScan, 200um

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 20, 2019

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

K930981,K930981

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

2a62cec9-f2e5-4bd2-91a0-24c7fdd310e9

Public Version Date

May 21, 2019

Public Version Number

4

DI Record Publish Date

September 26, 2016

Package DI Number

17290109140817

Quantity per Package

10

Contains DI Package

07290109140810

Package Discontinue Date

May 20, 2019

Package Status

Not in Commercial Distribution

Package Type

-