Noga-Star 120706S

GUDID 10846835002034

BIOSENSE WEBSTER INC.

Cardiac mapping catheter, percutaneous, single-use

• Primary Device ID: 10846835002034
• NIH Device Record Key: fbcc7f16-880a-4737-805b-03f44a5313b5
• Commercial Distribution Discontinuation: 2019-03-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Noga-Star
• Version Model Number: 120706S
• Catalog Number: 120706S
• Company DUNS: 020163218
• Company Name: BIOSENSE WEBSTER 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: 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

Customer Support Contacts

• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846835002034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954390

FDA Product Code

• DRF: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-01-15
• Device Publish Date: 2016-09-16

On-Brand Devices [Noga-Star]

• 10846835002058: 120708S
• 10846835002041: 120707S
• 10846835002034: 120706S
• 10846835002027: 120705S