N/A 401576

GUDID 00885825006822

Steerable Diagnostic EP Catheter, SMALL SWEEP, 4 electrodes, 2-5-2mm spacing, 7F

STRYKER SUSTAINABILITY SOLUTIONS, INC.

Cardiac mapping catheter, percutaneous, reprocessed

• Primary Device ID: 00885825006822
• NIH Device Record Key: 070a8c30-acc1-4739-8814-3ca8721220e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: N/A
• Catalog Number: 401576
• 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
• 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

• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter
• Length: 115 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885825006822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052603

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: 2016-09-23

On-Brand Devices [N/A]

• 00885825021030: JET-X Mini Clamp 6mm to 4mm
• 00885825021023: Carbon Rod
• 00885825021016: Carbon Fiber Rod
• 00885825020958: Diagnostic Ultrasound Catheter, 8F
• 00885825020941: Diagnostic Ultrasound Catheter, 10F
• 00885825020927: Diagnostic Ultrasound Catheter, 8F
• 00885825020910: Diagnostic Ultrasound Catheter, 10F
• 00885825020903: Restep Pump
• 30885825020898: Bladeless Trocar w/Stability Sleeve
• 00885825020880: Fast FX Strut 195mm to 311mm
• 00885825020859: Large Combination Clamp
• 00885825020842: Straight Post
• 00885825020835: Multi Pin Clamp
• 00885825020828: Angled Post
• 00885825020811: Pin Clamp
• 00885825020804: Rod to Rod Clamp
• 00885825020798: Carbon Fiber Rod
• 00885825020781: Carbon Fiber Rod
• 00885825020774: Carbon Fiber Rod
• 00885825020767: Carbon Fiber Rod
• 00885825020750: Carbon Fiber Rod
• 00885825020743: Carbon Fiber Rod
• 00885825020736: Carbon Fiber Rod
• 00885825020729: Carbon Fiber Rod
• 00885825020712: Carbon Fiber Rod
• 00885825020705: Carbon Fiber Rod
• 00885825020699: Carbon Fiber Rod
• 00885825020682: Carbon Fiber Rod
• 00885825020675: MonoTube Triax Pin Clamp External Fixation System
• 00885825020668: Adjustable Clamp
• 00885825020651: 30 Degress Outrigger Post
• 00885825020644: Outrigger Post
• 00885825020637: Pin Clamp
• 00885825020620: Pin Clamp
• 00885825020613: Adjustable Clamp
• 00885825020606: Adjustable Clamp
• 00885825020590: Tube to Tube Clamp
• 00885825020583: Multi-Pin Clamp
• 00885825020576: Rod Attachment
• 00885825020569: Multi-Pin Clamp
• 00885825020361: Universal Clamp
• 00885825020354: Universal Clamp
• 00885825020347: Universal Clamp
• 00885825020330: Rod to Rod Clamp
• 00885825020323: Rod to Rod Clamp
• 00885825020316: Rod to Rod Clamp
• 00885825020309: Rod to Rod Clamp
• 00885825020293: Rod to Rod Clamp
• 00885825020286: Carbon Fiber Rod
• 00885825020279: Carbon Fiber Rod