Catalog Number

-

Brand Name

Selecta Duet

Version/Model Number

Selecta Duet

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

K081704

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

a553e804-b7c9-42f9-a312-6b6fa72109f8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-