SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System 3001

GUDID 08600035053013

SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System. Small size.

East End Medical I LLC

Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon

• Primary Device ID: 08600035053013
• NIH Device Record Key: edadb073-5845-45c0-bd8f-b67c73d0ca54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System
• Version Model Number: 3001
• Catalog Number: 3001
• Company DUNS: 118148023
• Company Name: East End Medical I LLC
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08600035053013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203459

FDA Product Code

• DYB: Introducer, 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: 2022-04-13
• Device Publish Date: 2022-04-05

On-Brand Devices [SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System]

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