Catalog Number

-

Brand Name

OSYHAND

Version/Model Number

OSYHAND

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

K073617,K073617

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

6eee60a9-0a41-422b-8c35-4a87ee5765e4

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

October 12, 2016

Package DI Number

03760227850181

Quantity per Package

10

Contains DI Package

03760227850174

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard