SporGon 4301

GUDID 00864780000311

SporGon is a sterilant cleaning solution used in labs to clean surfaces, equipment and medical devices.

DECON LABORATORIES, INC.

Hydrogen peroxide device sterilant

• Primary Device ID: 00864780000311
• NIH Device Record Key: 0fa4b3ff-112a-44d7-a8dc-4314cf202b91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SporGon
• Version Model Number: 1 Gallon Bottle
• Catalog Number: 4301
• Company DUNS: 007089246
• Company Name: DECON LABORATORIES, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864780000311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972708

FDA Product Code

• MED: Sterilant, Medical Devices

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: 2018-07-06
• Device Publish Date: 2016-12-02