Catalog Number

PM-PA-PA

Brand Name

AccuBoost

Version/Model Number

450123-02

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

-

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

K863890

Product Code

IWJ

Product Code Name

System, Applicator, Radionuclide, Manual

Public Device Record Key

fb16d5ce-ae10-43e8-a943-39649ffbc39d

Public Version Date

December 11, 2019

Public Version Number

1

DI Record Publish Date

December 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-