Merci 9F 90077

GUDID 00815742000771

Balloon Guide Catheter

Stryker Corporation

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00815742000771
• NIH Device Record Key: 43cc7a81-bce5-4ff6-ae20-2cd2af9b9a09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merci 9F
• Version Model Number: 90077
• Catalog Number: 90077
• Company DUNS: 042405446
• Company Name: Stryker Corporation
• 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(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com

Device Dimensions

• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter
• Catheter Gauge: 9 French
• Length: 80 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815742000771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112404

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-09-21

On-Brand Devices [Merci 9F]

• 00815742000771: Balloon Guide Catheter
• 00815742000740: Balloon Guide Catheter