Sonostik Guide Wire Not Applicable

GUDID 00840155413290

Sonostik Guide Wire

MEDSOURCE INTERNATIONAL LLC

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00840155413290
• NIH Device Record Key: 934cd432-fa10-47dc-9aa9-149411fc0d0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonostik Guide Wire
• Version Model Number: MS-88300
• Catalog Number: Not Applicable
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840155413290 [Primary]

FDA Product Code

• DYB: Introducer, 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: 2022-07-29
• Device Publish Date: 2022-07-21

Devices Manufactured by MEDSOURCE INTERNATIONAL LLC

• 00840155401419 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 14Gx1.25
• 00840155406179 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 16Gx1.25
• 00840155413870 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 20Gx1.25
• 00840155413900 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 22Gx1
• 00840155413931 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 24Gx0.75
• 00840155413962 - MedSource Catheters: 2023-10-16 ClearSafe Comfort Closed System Dual Port 20Gx1
• 00840155413993 - MedSource Winged Catheters: 2023-10-16 ClearSafe Comfort I.V. Catheter, 14g x1.25 pur, winged
• 00840155414020 - MedSource Winged Catheters: 2023-10-16 ClearSafe Comfort I.V. Catheter, 16g x1.25 pur, winged