T2

GUDID 08800000995618

Osstem Implant Co.,Ltd.

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• Primary Device ID: 08800000995618
• NIH Device Record Key: 4c3481b6-0bb1-4b04-8204-09c823fcb229
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2
• Version Model Number: T2-CS
• Company DUNS: 694893867
• Company Name: Osstem Implant Co.,Ltd.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800000995618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212303

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

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: 2021-10-26
• Device Publish Date: 2021-10-18

On-Brand Devices [T2]

• 08800000995618: T2-CS
• 08800000995601: T2-C