Catalog Number

443620

Brand Name

PSW

Version/Model Number

1802.U

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 18, 2021

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

-

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

OSR

Product Code Name

Pacemaker/icd/crt non-implanted components

Public Device Record Key

5ca07562-65de-4a1b-a2c6-662b93401722

Public Version Date

August 19, 2021

Public Version Number

2

DI Record Publish Date

October 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-