VortX™ - 35 M0013733070

GUDID 08714729162759

VORTX 35 FIBERED COIL 3MM-7MM (1)

BOSTON SCIENTIFIC CORPORATION

Non-neurovascular embolization coil

• Primary Device ID: 08714729162759
• NIH Device Record Key: f236b438-ae8b-4a5a-9007-cee904da73f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VortX™ - 35
• Version Model Number: M0013733070
• Catalog Number: M0013733070
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729162759 [Package]; Contains: 08714729237303; Package: [5 Units]; In Commercial Distribution
GS1	08714729237303 [Primary]

FDA Product Code

• KRD: Device, Vascular, for Promoting Embolization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-09-24

On-Brand Devices [VortX™ - 35]

• 08714729162759: VORTX 35 FIBERED COIL 3MM-7MM (1)
• 08714729162742: VORTX 35 FIBERED COIL 3MM-6MM (1)
• 08714729162735: VORTX 35 FIBERED COIL 3MM-5MM (1)
• 08714729162728: VORTX 35 COIL 2MM-4MM (1)