Catalog Number

022804

Brand Name

SEW-EASY®

Version/Model Number

022804

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

-

Product Code

DWS

Product Code Name

INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Public Device Record Key

0615be21-60cc-4b58-822d-65bf68d62e15

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

March 13, 2020

Package DI Number

10850200006640

Quantity per Package

6

Contains DI Package

00850200006643

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case