SporGon

Basic Information

• Brand Name: SporGon
• Primary DI: 00864780000311
• Version / Model: 1 Gallon Bottle
• Catalog Number: 4301
• Company Name: DECON LABORATORIES, INC.
• Labeler DUNS: 007089246
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0fa4b3ff-112a-44d7-a8dc-4314cf202b91

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MED	Sterilant, Medical Devices	General Hospital	880.6885	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44835	Hydrogen peroxide device sterilant	A gaseous or liquid substance that includes hydrogen peroxide (H2O2) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. The substance may be presented in discrete quantities to accommodate the requirements of a sterilization device or system. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864780000311	GS1

Premarket Submissions

Submission Number	Supplement Number
K972708	000