Catalog Number

-

Brand Name

Jigsaw Medical,LLC

Version/Model Number

SVA47-S

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)

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

8aa24cdb-873b-46fe-b533-419c0c571703

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

September 23, 2020

Package DI Number

00856274008231

Quantity per Package

100

Contains DI Package

00856274008217

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case