Biosense Webster D134901

GUDID 07613327361957

STRYKER SUSTAINABILITY SOLUTIONS, INC.

Cardiac mapping catheter, percutaneous, reprocessed

• Primary Device ID: 07613327361957
• NIH Device Record Key: 011856e5-316b-4a7b-b021-7d09c200603b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biosense Webster
• Version Model Number: D134901
• Catalog Number: D134901
• 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

Device Dimensions

• Length: 115 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327361957 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112292

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: 2017-03-03

On-Brand Devices [Biosense Webster]

• 07613327361995: D134906
• 07613327361988: D134904
• 07613327361971: D134902
• 07613327361964: D134903
• 07613327361957: D134901
• 07613327361940: D134905
• 07613327359930: Diagnostic EP Catheter HALO XP, 7F
• 07613327359923: Diagnostic EP Catheter ISMUS, 7F