SOLO FLEX Hybrid Guidewires

GUDID 00816840020357

HERAEUS MEDICAL COMPONENTS, LLC

General-purpose non-vascular guidewire

• Primary Device ID: 00816840020357
• NIH Device Record Key: cc0b335f-4d1c-4325-90b6-2fa8d925e5de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLO FLEX Hybrid Guidewires
• Version Model Number: HW35FA
• Company DUNS: 080645456
• Company Name: HERAEUS MEDICAL COMPONENTS, LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816840020357 [Primary]

FDA Product Code

• EZB: Stylet For Catheter, Gastro-Urology

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: 2018-09-03
• Device Publish Date: 2018-08-01

On-Brand Devices [SOLO FLEX Hybrid Guidewires ]

• 00816840020449: HW38FAJ
• 00816840020432: HW38FSJ
• 00816840020425: HW35FAJ
• 00816840020418: HW35FSJ
• 00816840020364: HW38FA
• 00816840020357: HW35FA
• 00816840020333: HW35FS