Hex Button

GUDID 00846468063993

Hex Button 5.0mm

Pioneer Surgical Technology, Inc.

Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Internal orthopaedic fixation system, cerclage wire/cable, sterile Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw Implantable orthopaedic fixation device connection screw

• Primary Device ID: 00846468063993
• NIH Device Record Key: 1d8bbb1f-e0d9-4025-b7d7-3aae9674ba52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hex Button
• Version Model Number: 400-778
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, 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	00846468063993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992617

FDA Product Code

• HTN: Washer, Bolt Nut

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-08

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