OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS

GUDID 08800000995830

Osstem Implant Co.,Ltd.

Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer

• Primary Device ID: 08800000995830
• NIH Device Record Key: f8b1f94b-9182-4b53-ba84-e5a8a68a447a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
• Version Model Number: HYMIX
• Company DUNS: 695235881
• Company Name: Osstem Implant Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800000995830 [Primary]

FDA Product Code

• EFD: Amalgamator, Dental, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-08
• Device Publish Date: 2022-10-31

On-Brand Devices [OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS]

• 08800000995724: A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed
• 08800000995052: A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed
• 08800000995045: A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed
• 08800000995830: HYMIX