REFLEX Steerable Guidewire 502014B

GUDID 20705032054864

SGW REFLEX .014 175CM SOFT

CORDIS CORPORATION

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 20705032054864
• NIH Device Record Key: 216d6a3d-7032-4fe5-87e6-6eee93e51a4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFLEX Steerable Guidewire
• Version Model Number: 502014B
• Catalog Number: 502014B
• Company DUNS: 806136177
• Company Name: CORDIS 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	10705032054867 [Primary]
GS1	20705032054864 [Package]; Contains: 10705032054867; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905423

FDA Product Code

• DQX: Wire, guide, catheter

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: 2021-02-03
• Device Publish Date: 2021-01-26

On-Brand Devices [REFLEX Steerable Guidewire]

• 20705032054901: SGW REFLEX .014 175CM J SSOFT
• 20705032054864: SGW REFLEX .014 175CM SOFT
• 20705032054857: SGW REFLEX .014 175CM J STD