Sniper SBC0629-STR-165

GUDID 00853359008414

The Sniper is a dual lumen, 165cm, 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.

Embolx, Inc.

Peripheral vascular infusion catheter

• Primary Device ID: 00853359008414
• NIH Device Record Key: d0819543-2775-4fa0-9a21-f72b36e60013
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sniper
• Version Model Number: SBC0629-STR-165
• Catalog Number: SBC0629-STR-165
• Company DUNS: 079084339
• Company Name: Embolx, Inc.
• 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 Dimensions

• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter
• Catheter Working Length: 165 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853359008414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180904

FDA Product Code

• MJN: Catheter, Intravascular Occluding, Temporary

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: 2022-05-26
• Device Publish Date: 2022-05-18

On-Brand Devices [Sniper]

• 00853359008056: The Sniper is a dual lumen, 110cm, straight tip catheter comprised of an inner guidewire/infusio
• 00853359008049: The Sniper is a dual lumen, 130cm, straight tip catheter comprised of an inner guidewire/infusio
• 00853359008032: The Sniper is a dual lumen, 150cm, straight tip catheter comprised of an inner guidewire/infusio
• 00853359008025: The Sniper is a dual lumen, 150cm, straight tip catheter comprised of an inner guidewire/infusio
• 00853359008018: The Sniper is a dual lumen, 130cm, straight tip catheter comprised of an inner guidewire/infusio
• 00853359008001: The Sniper is a dual lumen, 110cm, straight tip catheter comprised of an inner guidewire/infusio
• B323SA00900: Infusion catheter with balloon occlusion
• 00853359008414: The Sniper is a dual lumen, 165cm, straight tip catheter comprised of an inner guidewire/infusio