Catalog Number

SK-037

Brand Name

SPORVIEW CULTURE STARTER KIT

Version/Model Number

SK-037

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)

Yes

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

K905425

Product Code

FRC

Product Code Name

Indicator, biological sterilization process

Public Device Record Key

078a47e4-e1ed-41ca-85d9-dd73128e4adb

Public Version Date

February 08, 2021

Public Version Number

3

DI Record Publish Date

November 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-