Zurpaz™ Steerable Sheath Set M004EPTMCA85400

GUDID 05391526210048

Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath

CREGANNA UNLIMITED COMPANY

Vascular guide-catheter, single-use

• Primary Device ID: 05391526210048
• NIH Device Record Key: 2910961a-8b92-4f1e-9793-6d73f424e6e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zurpaz™ Steerable Sheath Set
• Version Model Number: M004EPTMCA85400
• Catalog Number: M004EPTMCA85400
• Company DUNS: 985218606
• Company Name: CREGANNA UNLIMITED COMPANY
• 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 Dimensions

• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391526210048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131079

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-09-23

On-Brand Devices [Zurpaz™ Steerable Sheath Set]

• 05391526210086: Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath
• 05391526210079: Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath
• 05391526210062: Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath
• 05391526210055: Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath
• 05391526210048: Zurpaz™ Medium Curl, Asymmetric Curve Steerable Sheath
• 05391526210031: Zurpaz™ Medium Curl, Symmetric Curve Steerable Sheath