Catalog Number

-

Brand Name

N/A

Version/Model Number

DENTA II arm

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

K091320,K091320

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

38ed177d-f628-4fdc-9613-12f32d20b0db

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

8809447651538

Quantity per Package

1

Contains DI Package

08809447651521

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box