Catalog Number

3700

Brand Name

BIOlogical12

Version/Model Number

3700

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

85931f73-13e3-4ccb-9d2b-18b45b751e25

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 11, 2016

Package DI Number

50850065007811

Quantity per Package

6

Contains DI Package

10850065007813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case