Catalog Number

A21418

Brand Name

Jigsaw Medical, LLC

Version/Model Number

A21418

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

4665911c-600b-4c24-aa05-0c5ca62aab60

Public Version Date

August 22, 2019

Public Version Number

1

DI Record Publish Date

August 14, 2019

Package DI Number

00856274008033

Quantity per Package

100

Contains DI Package

00856274008002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case