Spore Check System

GUDID 00016724410001

Biological Indicator

OSHA REVIEW INC

Biological sterilization indicator

• Primary Device ID: 00016724410001
• NIH Device Record Key: 261b3431-1869-4596-8606-0bc8e1e9d4b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spore Check System
• Version Model Number: Dual-Spore
• Company DUNS: 944030360
• Company Name: OSHA REVIEW INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	00016724410001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905425

FDA Product Code

• FRC: Indicator, Biological Sterilization Process

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-10
• Device Publish Date: 2020-03-02

On-Brand Devices [Spore Check System]

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