2.4 mm Cortical Screw, Self-tapping, Star Head, 8mm length

GUDID 08903993317914

2.4 mm Cortical Screw, Self-tapping, Star Head, 8mm length

Auxein Medical Private Limited

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 08903993317914
• NIH Device Record Key: 70fc90da-1c00-4d1c-8fa0-180612bf5d78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.4 mm Cortical Screw, Self-tapping, Star Head, 8mm length
• Version Model Number: Ti-1144.08
• Company DUNS: 872194615
• Company Name: Auxein Medical Private Limited
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903993317914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211324

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[08903993317914]

Moist Heat or Steam Sterilization

[08903993317914]

Moist Heat or Steam Sterilization

[08903993317914]

Moist Heat or Steam Sterilization

[08903993317914]

Moist Heat or Steam Sterilization

[08903993317914]

Moist Heat or Steam Sterilization

[08903993317914]

Moist Heat or Steam Sterilization

[08903993317914]

Moist Heat or Steam Sterilization

[08903993317914]

Moist Heat or Steam Sterilization

[08903993317914]

Moist Heat or Steam Sterilization

[08903993317914]

Moist Heat or Steam Sterilization

[08903993317914]

Moist Heat or Steam Sterilization

[08903993317914]

Moist Heat or Steam Sterilization

[08903993317914]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-10
• Device Publish Date: 2022-05-02

On-Brand Devices [2.4 mm Cortical Screw, Self-tapping, Star Head, 8mm length]

• 08903993538838: Ti-1242.08S2.4 mm Cortical Screw, Self-tapping, Star Head, 8mm length
• 08903993317914: 2.4 mm Cortical Screw, Self-tapping, Star Head, 8mm length