N/A R10439236

GUDID 10888551045094

SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON GE IMAGING SYSTEM

STERILMED, INC.

Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed

• Primary Device ID: 10888551045094
• NIH Device Record Key: 6d805892-9c87-4932-91f0-585cfae25f74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: R10439236
• Catalog Number: R10439236
• Company DUNS: 175899459
• Company Name: STERILMED, 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(888)541-0078
• Email: customerservice@sterilmed.com
• Phone: +1(888)541-0078
• Email: customerservice@sterilmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888551045094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161700

FDA Product Code

• OWQ: Reprocessed intravascular ultrasound catheter

Sterilization

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

[10888551045094]

Ethylene Oxide

[10888551045094]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2017-02-15

On-Brand Devices [N/A]

• 10888551045094: SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON GE IMAGING SYSTEM
• 10888551045087: SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON SIEMENS IMAGING SYSTEM