Tilite Ceramic Alloys - Premium

GUDID D7911000

TALLADIUM, INC.

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• Primary Device ID: D7911000
• NIH Device Record Key: bc826a92-5b92-4e9a-bd7d-2d8e34b9ce55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tilite Ceramic Alloys - Premium
• Version Model Number: 100
• Company DUNS: 094430642
• Company Name: TALLADIUM, INC.
• 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: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7911000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894085

FDA Product Code

• EJH: Alloy, Metal, Base

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: 2016-10-24

On-Brand Devices [Tilite Ceramic Alloys - Premium]

• D791200: 120
• D7911000: 100
• D79110005: 5 oz of Tilite (Premium)