Steri-Vac™ GS8-2D

GUDID 50707387767278

3M™ Steri-Vac™ Sterilizer, 2 Door GS8-2D

3M COMPANY

Ethylene oxide sterilizer

• Primary Device ID: 50707387767278
• NIH Device Record Key: c4a816a0-b631-492a-a01b-0ee570c5cb2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steri-Vac™
• Version Model Number: GS8-2D
• Catalog Number: GS8-2D
• Company DUNS: 830016148
• Company Name: 3M COMPANY
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	50707387767278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142034

FDA Product Code

• FLF: Sterilizer, ethylene-oxide gas

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: 2016-09-24

On-Brand Devices [Steri-Vac™]

• 50707387767278: 3M™ Steri-Vac™ Sterilizer, 2 Door GS8-2D
• 50707387767261: 3M™ Steri-Vac™ Sterilizer, 1 Door GS8-1D
• 50707387767254: 3M™ Steri-Vac™ Sterilizer, 2 Door GS5-2D
• 50707387767247: 3M™ Steri-Vac™ Sterilizer, 1 Door GS5-1D