GS80 4402404

GUDID DO3644024042

SDI LIMITED

Dental amalgam alloy

• Primary Device ID: DO3644024042
• NIH Device Record Key: f9c3c640-861e-4c90-8ee2-db891827513f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GS80
• Version Model Number: GS80 2SP SLOW 50
• Catalog Number: 4402404
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 50
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18002285166
• Email: info@sdi.com.au

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3644024040 [Unit of Use]
HIBCC	DO3644024042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K801639

FDA Product Code

• EJJ: Alloy, amalgam

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: 2016-09-23

On-Brand Devices [GS80]

• DO3644603032: GS80 ALLOY REG 5OZ
• DO3644503032: GS80 TABS REG 5OZ
• DO3644250002: GS80 5SP REG 500
• DO3644234042: GS80 3SP SLOW 500
• DO3644233032: GS80 3SP REG 500
• DO3644232022: GS80 3SP FAST 500
• DO3644224042: GS80 2SP SLOW 500
• DO3644223032: GS80 2SP REG 500
• DO3644222022: GS80 2SP FAST 500
• DO3644214042: GS80 1SP SLOW 500
• DO3644213032: GS80 1SP REG 500
• DO3644212022: GS80 1SP FAST 500
• DO3644050002: GS80 5SP REG 50
• DO3644034042: GS80 3SP SLOW 50
• DO3644033032: GS80 3SP REG 50
• DO3644032022: GS80 3SP FAST 50
• DO3644024042: GS80 2SP SLOW 50
• DO3644023032: GS80 2SP REG 50
• DO3644022022: GS80 2SP FAST 50
• DO3644014042: GS80 1SP SLOW 50
• DO3644013032: GS80 1SP REG 50
• DO3644012022: GS80 1SP FAST 50