Catalog Number

-

Brand Name

25GA Straight Laser Probe, SMA905

Version/Model Number

GA-0042250

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"

Yes

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

K024061,K024061

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

a1c366b7-7c42-4722-b955-8512757491dc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

10632307002103

Quantity per Package

10

Contains DI Package

00632307002106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box