Procure™ 408296

GUDID 05415067009548

Endomyocardial Biopsy Forceps

ST. JUDE MEDICAL, INC.

Endomyocardial biopsy forceps, single-use

• Primary Device ID: 05415067009548
• NIH Device Record Key: 72c9fdf2-1e0e-45cb-acba-b9798c3cbb2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procure™
• Version Model Number: 408296
• Catalog Number: 408296
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, 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: 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

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 7 French
• Catheter Gauge: 7 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not use if package is damaged.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067009548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991486

FDA Product Code

• DWZ: DEVICE, BIOPSY, ENDOMYOCARDIAL

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: 2019-07-08
• Device Publish Date: 2016-04-21

On-Brand Devices [Procure™]

• 05415067009579: Endomycardial Biopsy Forceps
• 05415067009562: Endomycardial Biopsy Forceps
• 05415067009555: Endomyocardial Biopsy Forceps
• 05415067009548: Endomyocardial Biopsy Forceps
• 05415067009531: Endomyocardial Biopsy Forceps
• 05415067009524: Endomyocardial Biopsy Forceps
• 05415067009517: Endomyocardial Biopsy Forceps