Non-Locking Screw, 3.5mm x 46mm

GUDID 00848665026665

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00848665026665
• NIH Device Record Key: d4ab2d7e-ad7b-4bce-b869-2eeb86303d10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Locking Screw, 3.5mm x 46mm
• Version Model Number: 8084-046
• Company DUNS: 117858154
• Company Name: ADVANCED ORTHOPEDIC SOLUTIONS INC
• 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: false
• 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	00848665026665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152732

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00848665026665]

Moist Heat or Steam Sterilization

[00848665026665]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-04

Devices Manufactured by ADVANCED ORTHOPEDIC SOLUTIONS INC

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• 00848665001235 - AOS CANCELLOUS TAP 3.5mm: 2020-06-08
• 00848665027624 - SUPRAPATELLAR TIBIAL ENTRY SHEATH: 2020-06-08
• 00848665028041 - T10 Screwdriver, Short: 2020-06-08
• 00848665028096 - 3.5mm Calibrated Drill: 2020-06-08
• 00848665028119 - AOS 2.6mm Solid Reamer: 2020-06-08
• 00848665028782 - T10 Screwdriver, Solid: 2020-06-08