Approach Authority Workhorse Microwire Guide

GUDID 00816840020777

HERAEUS MEDICAL COMPONENTS LLC

Peripheral vascular guidewire, manual

• Primary Device ID: 00816840020777
• NIH Device Record Key: dbf434e2-1d88-4f66-a3d8-8e086627bbef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Approach Authority Workhorse Microwire Guide
• Version Model Number: AUTH-18-300
• Company DUNS: 868303074
• Company Name: HERAEUS MEDICAL COMPONENTS LLC
• 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	00816840020777 [Primary]

FDA Product Code

• DQX: Wire, Guide, Catheter

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: 2020-06-29
• Device Publish Date: 2020-06-19

On-Brand Devices [Approach Authority Workhorse Microwire Guide]

• 00816840020777: AUTH-18-300
• 00816840020760: AUTH-18-190