Soft-Vu

GUDID H787107334035

Soft-Vu Angiographic Catheter, Rim, Braided

ANGIODYNAMICS, INC.

Angiographic catheter, single-use

• Primary Device ID: H787107334035
• NIH Device Record Key: f7ec23cf-8170-494e-9b74-bf0c545820bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soft-Vu
• Version Model Number: 10733403
• Company DUNS: 079105071
• Company Name: ANGIODYNAMICS, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Device Dimensions

• Outer Diameter: 1.4 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684009911 [Secondary]
HIBCC	H787107334030 [Primary]
HIBCC	H787107334035 [Package]; Contains: H787107334030; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112452

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-21
• Device Publish Date: 2016-09-14

On-Brand Devices [Soft-Vu]

• 15051684016094: Soft-Vu Angiographic Catheter, Omega, Braided
• 15051684016087: Soft-Vu Angiographic Catheter, Omega, Non-Braided
• 15051684016070: Soft-Vu Angiographic Catheter, Omega, Braided
• 15051684016063: Soft-Vu Angiographic Catheter, Sharp Angle, Non-Braided
• 15051684016056: Soft-Vu Angiographic Catheter, Sharp Angle, Braided
• 15051684016049: Soft-Vu Angiographic Catheter, Sharp Angle, Braided
• 15051684016032: Soft-Vu Angiographic Catheter, Sharp Angle, Non-Braided
• 15051684016025: Soft-Vu Angiographic Catheter, Sharp Angle, Braided
• 15051684016018: Soft-Vu Angiographic Catheter, Sharp Angle, Non-Braided
• 15051684016001: Soft-Vu Angiographic Catheter, Sharp Angle, Braided
• 15051684015998: Soft-Vu Angiographic Catheter, Sharp Angle, Non-Braided
• 15051684015981: Soft-Vu Angiographic Catheter, Sharp Angle, Braided
• 15051684015974: Soft-Vu Angiographic Catheter, Sharp Angle, Non-Braided
• 15051684015967: Soft-Vu Angiographic Catheter, Sharp Angle, Braided
• 15051684015950: Soft-Vu Angiographic Catheter, NaviGate (5), Non-Braided
• 15051684015943: Soft-Vu Angiographic Catheter, NaviGate (4), Non-Braided
• 15051684015936: Soft-Vu Angiographic Catheter, NaviGate (3), Non-Braided
• 15051684015929: Soft-Vu Angiographic Catheter, NaviGate (2), Non-Braided
• 15051684015912: Soft-Vu Angiographic Catheter, NaviGate (1), Non-Braided
• 15051684015905: Soft-Vu Angiographic Catheter, Vertebral, Non-Braided
• 15051684015899: Soft-Vu Angiographic Catheter, Vertebral, Braided
• 15051684015882: Soft-Vu Angiographic Catheter, Vertebral, Non-Braided
• 15051684015875: Soft-Vu Angiographic Catheter, Vertebral, Braided
• 15051684015868: Soft-Vu Angiographic Catheter, Vertebral, Braided
• 15051684015851: Soft-Vu Angiographic Catheter, Vertebral, Braided
• 15051684015844: Soft-Vu Angiographic Catheter, Vertebral, Non-Braided
• 15051684015837: Soft-Vu Angiographic Catheter, Vertebral, Braided
• 15051684015820: Soft-Vu Angiographic Catheter, Sidewinder 2 ST, Braided
• 15051684015813: Soft-Vu Angiographic Catheter, Sidewinder (2), Braided
• 15051684015806: Soft-Vu Angiographic Catheter, Sidewinder (2), Non-Braided
• 15051684015790: Soft-Vu Angiographic Catheter, Sidewinder 2 ST, Non-Braided
• 15051684015783: Soft-Vu Angiographic Catheter, Sidewinder 2 ST, Braided
• 15051684015776: Soft-Vu Angiographic Catheter, Sidewinder 1 ST, Non-Braided
• 15051684015769: Soft-Vu Angiographic Catheter, Sidewinder 1 ST, Non-Braided
• 15051684015752: Soft-Vu Angiographic Catheter, Sidewinder 1 ST, Non-Braided
• 15051684015745: Soft-Vu Angiographic Catheter, Sidewinder 1 ST, Braided
• 15051684015738: Soft-Vu Angiographic Catheter, Sidewinder 1 ST, Braided
• 15051684015721: Soft-Vu Angiographic Catheter, Sidewinder 1 ST, Braided
• 15051684015714: Soft-Vu Angiographic Catheter, Straight Art, Non-Braided
• 15051684015707: Soft-Vu Angiographic Catheter, Straight Art, Non-Braided
• 15051684015691: Soft-Vu Angiographic Catheter, Straight Art, Braided
• 15051684015684: Soft-Vu Angiographic Catheter, Straight Art, Non-Braided
• 15051684015677: Soft-Vu Angiographic Catheter, Straight Art, Non-Braided
• 15051684015660: Soft-Vu Angiographic Catheter, Straight Flush, Non-Braided
• 15051684015653: Soft-Vu Angiographic Catheter, Straight Flush, Non-Braided
• 15051684015646: Soft-Vu Angiographic Catheter, Sos OmniSelective (3), Non-Braided
• 15051684015639: Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided
• 15051684015554: Soft-Vu Angiographic Catheter, Sos Omni Selective 0, Non-Braided
• 15051684015547: Soft-Vu Angiographic Catheter, Sos Omni Selective 0, Braided
• 15051684015530: Soft-Vu Angiographic Catheter, Shepherd Hook (2), Braided