IRVINE BIOMEDICAL INC. D087024

GUDID 07613327395969

Steerable Diagnostic EP Catheter, 20mm(A-FOCUS), 20 electrodes, 1-2.5mm spacing, 7F

STRYKER SUSTAINABILITY SOLUTIONS, INC.

Cardiac mapping catheter, percutaneous, reprocessed

• Primary Device ID: 07613327395969
• NIH Device Record Key: 2e1e8d8e-f1b9-4a1b-849a-dfa3774aff54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRVINE BIOMEDICAL INC.
• Version Model Number: D087024
• Catalog Number: D087024
• Company DUNS: 020198912
• Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com
• Phone: +1(888)888-3433
• Email: RegulatoryAffairs2@stryker.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter
• Device Size Text, specify: 0
• Length: 110 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327395969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112232

FDA Product Code

• NLH: CATHETER, RECORDING, ELECTRODE, REPROCESSED

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: 2018-07-06
• Device Publish Date: 2017-11-03

On-Brand Devices [IRVINE BIOMEDICAL INC.]

• 07613327402117: Steerable Diagnostic EP Catheter, 15mm(A-FOCUS), 10 electrodes, 3mm spacing, 7F
• 07613327395969: Steerable Diagnostic EP Catheter, 20mm(A-FOCUS), 20 electrodes, 1-2.5mm spacing, 7F