Vascular Probe

Basic Information

• Brand Name: Vascular Probe
• Primary DI: 00085412532547
• Version / Model: 7082025
• Catalog Number: 7082025
• Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.
• Labeler DUNS: 017415781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: fd93a3b3-2a88-416f-b76a-2b227f10623e

Device Description

The Vascular Probe is a sterile, single use, disposable polymeric device with a streamline bulb on each end of a flexible shaft. The bulbs are of different size on each end of the Vascular Probe.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWP	DILATOR, VESSEL, SURGICAL	Cardiovascular	870.4475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47846	Intravascular probe, single-use	A slender, rod-like, hand-held manual surgical instrument intended to facilitate vessel stenting, retraction, and occlusion. It is inserted into the vessel lumen via a small incision to locate occlusions, explore the proximal/distal artery for size, patency and location of stenosis, and to arrest blood flow (proximally, distally, or both) to enable operative field visualization during coronary or peripheral vascular bypass grafting and vessel repair surgery. It may be single- or double-ended with a blunt bulbous tip (an olive) at the working end(s); It is typically made of polyester/silicone materials and is available in various sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50085412532542	GS1	CASE	5	In Commercial Distribution
Primary	00085412532547	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K130896	000