GS80

Basic Information

• Brand Name: GS80
• Primary DI: DO3644213032
• Version / Model: GS80 1SP REG 500
• Catalog Number: 4421303
• Company Name: SDI LIMITED
• Labeler DUNS: 753221852
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2025-01-13
• Public Version Status: Update
• Public Device Record Key: 1ef7c292-a2a4-4307-9892-2dda97cb7000
• Distribution End Date: 2025-01-12

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
EJJ	Alloy, amalgam	Dental	872.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34836	Dental amalgam alloy	A composite of metals in fine particles, consisting mainly of silver (Ag), tin (Sn) and small amounts of copper (Cu), that is intended for mixing with mercury (Hg) to produce dental amalgam. Amalgam is a dental restorative material used to fill tooth cavities. 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	DO3644213032	HIBCC
Unit of Use	DO3644213030	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K801639	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: – 25 Degrees Celsius