Catalog Number

62099

Brand Name

SmartPractice

Version/Model Number

62099

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FRC

Product Code Name

Indicator, biological sterilization process

Public Device Record Key

7ada041e-1820-4a0c-9da7-e66cfb2e2862

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 08, 2016

Package DI Number

D766620992

Quantity per Package

6

Contains DI Package

D766620991

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-