Catalog Number

445665

Brand Name

PSW

Version/Model Number

1901.U

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 24, 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

P950037

Product Code

OSR

Product Code Name

Pacemaker/icd/crt non-implanted components

Public Device Record Key

6e014a07-b343-4567-b05c-1ed779200ecc

Public Version Date

August 25, 2021

Public Version Number

2

DI Record Publish Date

July 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-