6 Hole Malleolar Gridlock Hook Plate

GUDID 00812926027647

TRILLIANT SURGICAL, LTD.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00812926027647
• NIH Device Record Key: a0b2d258-bf98-4198-9400-af30ee7e748d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 6 Hole Malleolar Gridlock Hook Plate
• Version Model Number: 300-64-001
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00812926027647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160177

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

[00812926027647]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-14
• Device Publish Date: 2019-01-14

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