A&E Medical / SternaLock® XP Rigid Fixation System

GUDID 10841291107170

ZDrive™ Blade, Sternalock® XP

A & E MEDICAL CORPORATION

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• Primary Device ID: 10841291107170
• NIH Device Record Key: 260ddb3d-ad4c-41e2-8516-fb529c225025
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A&E Medical / SternaLock® XP Rigid Fixation System
• Version Model Number: 73-1195
• Company DUNS: 173770868
• Company Name: A & E MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	10841291107170 [Primary]

FDA Product Code

• HRS: Plate, 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: 2022-01-20
• Device Publish Date: 2022-01-12

Devices Manufactured by A & E MEDICAL CORPORATION

• 10841291107255 - SternaLock® XP Bone Screw, 2.7mm x 14mm, 4 Pack: 2022-12-14 Bone Screw, 2.7mm x 14mm, 4 Pack
• 10841291107262 - SternaLock® XP Bone Screw, 2.7mm x 10mm, 4 Pack: 2022-12-14 Bone Screw, 2.7mm x 10mm, 4 Pack
• 10841291107279 - SternaLock® XP Bone Screw, 3.0mm x 14mm, 2 Pack: 2022-12-14 Bone Screw, 3.0mm x 14mm, 2 Pack
• 10841291107286 - SternaLock® XP Bone Screw, 3.0mm x 10mm, 2 Pack: 2022-12-14 Bone Screw, 3.0mm x 10mm, 2 Pack
• 10841291107330 - SternaLock® XP Bone Screw, 2.7mm x 10mm, 6 Pack: 2022-12-14 Bone Screw, 2.7mm x 10mm, 6 Pack
• 10841291107347 - SternaLock® XP Bone Screw, 2.7mm x 10mm, 8 Pack: 2022-12-14 Bone Screw, 2.7mm x 10mm, 8 Pack
• 10841291107354 - SternaLock® XP Bone Screw, 2.7mm x 14mm, 6 Pack: 2022-12-14 Bone Screw, 2.7mm x 14mm, 6 Pack
• 10841291107361 - SternaLock® XP Bone Screw, 2.7mm x 14mm, 8 Pack: 2022-12-14 Bone Screw, 2.7mm x 14mm, 8 Pack