Sniper

Basic Information

• Brand Name: Sniper
• Primary DI: 00853359008018
• Version / Model: SBC0629-130
• Catalog Number: SBC0629-130
• Company Name: Embolx, Inc.
• Labeler DUNS: 079084339
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-22
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 2ae19069-4aeb-4c23-a430-a4292f8989fa

Device Description

The Sniper is a dual lumen, 130cm, straight tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon.

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: Yes
• 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
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32151	Peripheral vascular intervention infusion catheter	A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853359008018	GS1

Device Sizes

Type	Value	Unit	Text
Length	130	Centimeter