Flextra Steerable Introducer

GUDID 00852392007002

Flextra - 50cm - MED Curl Flextra Steerable Introducer 50cm Med Curl 8.5F

RHYTHM XIENCE, INC.

Cardiac transseptal access set

• Primary Device ID: 00852392007002
• NIH Device Record Key: f04fd526-fd63-4112-b209-923ddc63d036
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flextra Steerable Introducer
• Version Model Number: 122851
• Company DUNS: 035028367
• Company Name: RHYTHM XIENCE, 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: true
• Manufacturing Date: true
• 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	00852392007002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170373

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

[00852392007002]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-01-23
• Device Publish Date: 2018-10-29

On-Brand Devices [Flextra Steerable Introducer]

• 00852392007019: Flextra - 65cm - MED Curl Flextra Steerable Introducer 65cm Med Curl 8.5F
• 00852392007002: Flextra - 50cm - MED Curl Flextra Steerable Introducer 50cm Med Curl 8.5F