Depth Gauge, 32mm

GUDID 00810054091059

Depth Gauge, 32mm

AVANTI ORTHOPAEDICS LLC

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

• Primary Device ID: 00810054091059
• NIH Device Record Key: 69d38cf5-3892-40d5-b3b3-c7b973591b1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Depth Gauge, 32mm
• Version Model Number: DI32
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810054091059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191118

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00810054091059]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-19
• Device Publish Date: 2020-06-18

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