Catalog Number

D624MS

Brand Name

Gentle Pulse™

Version/Model Number

D624MS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2019

Issuing Agency

In HIBCC

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

EAT

Product Code Name

Tester, Pulp

Public Device Record Key

f99f52d7-b514-4638-aee5-660904a0f2eb

Public Version Date

April 01, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-