Lag Screw, 3.2mm x 12mm Long

GUDID 00810054091455

Lag Screw, 3.2mm x 12mm Long

AVANTI ORTHOPAEDICS LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00810054091455
• NIH Device Record Key: 4ec6707f-6c92-4750-bae1-0043b7add822
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lag Screw, 3.2mm x 12mm Long
• Version Model Number: LG3212
• Company DUNS: 043505370
• Company Name: AVANTI ORTHOPAEDICS LLC
• 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: true
• 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

Customer Support Contacts

• Phone: 610-316-7345
• Email: info@avantiortho.com
• Phone: 610-316-7345
• Email: info@avantiortho.com
• Phone: 610-316-7345
• Email: info@avantiortho.com
• Phone: 610-316-7345
• Email: info@avantiortho.com
• Phone: 610-316-7345
• Email: info@avantiortho.com
• Phone: 610-316-7345
• Email: info@avantiortho.com
• Phone: 610-316-7345
• Email: info@avantiortho.com
• Phone: 610-316-7345
• Email: info@avantiortho.com
• Phone: 610-316-7345
• Email: info@avantiortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810054091455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211592

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00810054091455]

Moist Heat or Steam Sterilization

[00810054091455]

Moist Heat or Steam Sterilization

[00810054091455]

Moist Heat or Steam Sterilization

[00810054091455]

Moist Heat or Steam Sterilization

[00810054091455]

Moist Heat or Steam Sterilization

[00810054091455]

Moist Heat or Steam Sterilization

[00810054091455]

Moist Heat or Steam Sterilization

[00810054091455]

Moist Heat or Steam Sterilization

[00810054091455]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-05
• Device Publish Date: 2021-07-28

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