Direxion™ Fathom™-16 System M001195990

GUDID 08714729991090

Pre-Loaded Torqueable Microcatheter

BOSTON SCIENTIFIC CORPORATION

Vascular microcatheter

• Primary Device ID: 08714729991090
• NIH Device Record Key: 1e0aae47-3f40-4e78-9be9-7c0163f7743b
• Commercial Distribution Discontinuation: 2021-08-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Direxion™ Fathom™-16 System
• Version Model Number: M001195990
• Catalog Number: M001195990
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter
• Catheter Inner Diameter: 0.021 Inch
• Catheter Working Length: 155 Centimeter
• Guidewire Length: 200 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729991090 [Primary]

FDA Product Code

• KRA: Catheter, continuous flush

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-25
• Device Publish Date: 2019-07-25

On-Brand Devices [Direxion™ Fathom™-16 System]

• 08714729991090: Pre-Loaded Torqueable Microcatheter
• 08714729991083: Pre-Loaded Torqueable Microcatheter