Catalog Number

SA-06452

Brand Name

PASCAL Synthesis TwinStar

Version/Model Number

PASCAL Synthesis TwinStar (577/638)- PA04

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

K170409

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

edeb1a70-46c3-41d9-ae33-aa653f64b16f

Public Version Date

November 18, 2019

Public Version Number

2

DI Record Publish Date

September 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-