2.7mm Cortical Screw, Self-Tapping, (Star Head), 8mm length

GUDID 08903993538708

2.7mm Cortical Screw, Self-Tapping, (Star Head), 8mm length

Auxein Medical Private Limited

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 08903993538708
• NIH Device Record Key: fb6e40b9-2109-463f-982b-cf0df1764721
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.7mm Cortical Screw, Self-Tapping, (Star Head), 8mm length
• Version Model Number: Ti-1242.08S
• 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: true
• 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	08903993538708 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211324

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-06
• Device Publish Date: 2022-04-28

On-Brand Devices [2.7mm Cortical Screw, Self-Tapping, (Star Head), 8mm length]

• 08903993538708: 2.7mm Cortical Screw, Self-Tapping, (Star Head), 8mm length
• 08903993439081: 2.7mm Cortical Screw, Self-Tapping, (Star Head), 8mm length