PREMIOtitan

GUDID D831TI10

PRIMOTEC LLC

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• Primary Device ID: D831TI10
• NIH Device Record Key: cbe7d1a1-79e3-42f6-959b-57b5f7f2c23c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREMIOtitan
• Version Model Number: TI-10
• Company DUNS: 153454736
• Company Name: PRIMOTEC LLC
• 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: 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	D831TI10 [Primary]

FDA Product Code

• EJH: Alloy, Metal, Base

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: 2020-09-07
• Device Publish Date: 2020-08-28

On-Brand Devices [PREMIOtitan]

• D831TI20: TI-20
• D831TI18: TI-18
• D831TI15: TI-15
• D831TI135: TI-13.5
• D831TI12: TI-12
• D831TI10: TI-10