Hex Button

GUDID 00846468064020

Hex Button 3.5mm

Pioneer Surgical Technology, Inc.

Internal orthopaedic fixation system, cerclage wire/cable, sterile

• Primary Device ID: 00846468064020
• NIH Device Record Key: 5de03227-8515-4789-88a1-4285bff44cea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hex Button
• Version Model Number: 400-783
• 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	00846468064020 [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

On-Brand Devices [Hex Button]

• 00846468064037: Hex Button 5.0mm
• 00846468064020: Hex Button 3.5mm
• 00846468064006: Hex Button 2.5mm
• 00846468063993: Hex Button 5.0mm
• 00846468063986: Hex Button 3.5mm
• 00846468063979: Hex Button 2.5mm