Catalog Number

-

Brand Name

SpeedLyser

Version/Model Number

12800204

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

K033443,K170258

Product Code

QEY

Product Code Name

Mechanical thrombolysis catheter

Public Device Record Key

e1f02b83-a5ba-4d05-bae7-ef78819d22e2

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

September 21, 2016

Package DI Number

H787128002045

Quantity per Package

5

Contains DI Package

H787128002040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX