Catalog Number

ASAP100/G

Brand Name

ASAP®

Version/Model Number

00884450568385

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K212199,K212199

Product Code

QEZ

Product Code Name

Aspiration thrombectomy catheter

Public Device Record Key

9c5fec65-b62e-41a0-8e82-38e5f20c8640

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

March 04, 2022

Package DI Number

10884450568382

Quantity per Package

3

Contains DI Package

00884450568385

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-