Spore Check System

GUDID 00016724110000

Biological Indicator

OSHA REVIEW INC

Biological sterilization indicator

• Primary Device ID: 00016724110000
• NIH Device Record Key: dc16f5ce-01bd-454b-bafe-eb05d254400b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spore Check System
• Version Model Number: Geobacillus stearothermophilus
• Company DUNS: 944030360
• Company Name: OSHA REVIEW INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 916-362-7488
• Email: info@oshareview.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00016724110000 [Primary]

FDA Product Code

• FRC: Indicator, Biological Sterilization Process

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-09
• Device Publish Date: 2016-09-26

On-Brand Devices [Spore Check System]

• 00016724310004: Biological Indicator
• 00016724110000: Biological Indicator
• 00016724410001: Biological Indicator