12mm HTR Implant System, Non-Sterile

GUDID 00812926027128

TRILLIANT SURGICAL, LTD.

Orthopaedic bone wire

• Primary Device ID: 00812926027128
• NIH Device Record Key: 064443fb-f7a2-4e4e-b05b-da2f7ddd3a8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 12mm HTR Implant System, Non-Sterile
• Version Model Number: 220-12-004
• Company DUNS: 828829072
• Company Name: TRILLIANT SURGICAL, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812926027128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121008

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

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

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

[00812926027128]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-05

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