9 Hole 1/3 Tubular Gridlock Ankle Plate

GUDID 00812926027616

TRILLIANT SURGICAL, LTD.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00812926027616
• NIH Device Record Key: c47d27f9-0afd-4577-a469-57c3f1efcee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 9 Hole 1/3 Tubular Gridlock Ankle Plate
• Version Model Number: 300-63-002
• 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: true
• 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	00812926027616 [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

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

[00812926027616]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-28

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