Catalog Number

022540

Brand Name

SEW-EASY®

Version/Model Number

022540

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

b4a78f7a-468a-4bf7-8471-b55eec65a444

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

March 13, 2020

Package DI Number

10850200006886

Quantity per Package

12

Contains DI Package

00850200006889

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box