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

K191501,K191501,K191501

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

85c2df5e-546a-4d43-b31f-6b6d6b8155e1

Public Version Date

February 18, 2020

Public Version Number

1

DI Record Publish Date

February 10, 2020

Package DI Number

00088000355931

Quantity per Package

1

Contains DI Package

08800035500894

Package Discontinue Date

February 10, 2020

Package Status

Not in Commercial Distribution

Package Type

Carton Box