SOLO PLUS Stiff Hybrid Guidewires

GUDID 00816840020302

HERAEUS MEDICAL COMPONENTS, LLC

General-purpose non-vascular guidewire General-purpose non-vascular guidewire General-purpose non-vascular guidewire Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use

• Primary Device ID: 00816840020302
• NIH Device Record Key: 1c6b1cea-2e91-482c-b453-3d7ca552891e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLO PLUS Stiff Hybrid Guidewires
• Version Model Number: HW38SS
• 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	00816840020302 [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

Devices Manufactured by HERAEUS MEDICAL COMPONENTS, LLC

• 00857834006605 - Odyssey Micro Catheter: 2019-04-09
• 00857834006933 - Odyssey Micro Catheter: 2019-04-09
• 00857834006070 - ERCP: 2018-10-05
• 00857834006087 - ERCP: 2018-10-05
• 00857834006094 - ERCP: 2018-10-05
• 00857834006100 - ERCP: 2018-10-05
• 00857834006117 - ERCP: 2018-10-05
• 00857834006124 - ERCP: 2018-10-05