3.5mm Wise-Lock Screws, Self Tapping, Length 18 mm A3-DND-QF-001-WF3

GUDID 08903993258255

Screws are used to affix the plate to the bone

Auxein Medical Private Limited

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

• Primary Device ID: 08903993258255
• NIH Device Record Key: 6ea96d82-1068-44d9-85e4-78360153cca4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5mm Wise-Lock Screws, Self Tapping, Length 18 mm
• Version Model Number: 117.018
• Catalog Number: A3-DND-QF-001-WF3
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9910643638
• Email: INFO@AUXEIN.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903993258255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141680

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[08903993258255]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-18
• Device Publish Date: 2018-11-30

On-Brand Devices [3.5mm Wise-Lock Screws, Self Tapping, Length 18 mm]

• 08903993259108: Screws are used to affix the plate to the bone
• 08903993258255: Screws are used to affix the plate to the bone