Catalog Number

-

Brand Name

PALLAS body

Version/Model Number

PALLAS body

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

K172639,K172639,K172639

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

682b5502-8041-4239-b036-32be74b3c24d

Public Version Date

November 21, 2019

Public Version Number

5

DI Record Publish Date

January 15, 2018

Package DI Number

08800035500313

Quantity per Package

1

Contains DI Package

08800035500245

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box