N/A 0894-000-004

GUDID 07613327622782

SC+ AI Software

STRYKER CORPORATION

Blood loss estimation application software

• Primary Device ID: 07613327622782
• NIH Device Record Key: e194a993-379c-4853-bc43-24ff4ab53db7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 0894000004
• Catalog Number: 0894-000-004
• Company DUNS: 196548481
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com
• Phone: +0018002533210
• Email: inst.stryker.cs@stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327622782 [Primary]

FDA Product Code

• PBZ: Image processing device for estimation of external blood loss

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-20
• Device Publish Date: 2024-02-12

On-Brand Devices [N/A]

• 07613327402278: 2.5mm Extended Match Head
• 07613327402254: 2.5mm Extended Precision Match Head
• 37613327381451: 12cm Elite Irrigation Sleeve
• 37613327381444: 16cm MIS Irrigation Sleeve
• 37613327381437: 7cm Elite Irrigation Sleeve
• 37613327381420: 13cm MIS Irrigation Sleeve
• 07613327363616: Hybrid Insert Tray
• 07613327311891: Bipolar Generator Coag-Only Single Foot Pedal
• 37613327304269: Bipolar Cord Set, Disposable
• 37613327304252: Integrated Tubing and Bipolar Cord Set, Disposable, Unitized Plug
• 37613327304245: Integrated Tubing and Bipolar Cord Set, Disposable
• 37613327304221: Bipolar Cord Set, Disposable, Unitized Plug
• 37613327304207: Bipolar Irrigator Integrated Tubing and Bipolar Cord Set, Disposable, Unitized Plug
• 37613327304191: Bipolar Irrigator Integrated Tubing and Bipolar Cord Set, Disposable
• 07613327303902: Bipolar Generator Cart
• 07613327303896: Bipolar Irrigator Power Cord
• 07613327303889: Bipolar Generator
• 07613327303872: Bipolar Generator Cut/Coag Dual Foot Pedal
• 07613327303865: Bipolar Irrigator
• 07613327303858: Bipolar Foot Pedal Adapter Cable
• 07613327303841: Bipolar Generator/Irrigator Interconnect Cable
• 07613327294996: Precision Acorn
• 07613327294989: Carbide Match Head
• 07613327294972: Carbide Round
• 07613327294965: Diamond Match Head
• 07613327294958: Round Diamond, Extended
• 07613327294941: Round
• 07613327294934: Round Diamond
• 07613327294927: Carbide Round, Extended
• 07613327294910: Tapered Router
• 07613327294903: Round Diamond, Extended
• 07613327294897: Round, Extended
• 07613327294880: Spiral Router
• 07613327294873: Diamond Match Head
• 07613327294866: Round
• 07613327294859: Round
• 07613327294842: Carbide Round
• 07613327294835: Carbide Round, Extended
• 07613327294828: Round, Extended
• 07613327294811: Match Head
• 07613327294804: Round
• 07613327294798: Precision Acorn
• 07613327294781: Round Diamond
• 07613327294774: Precision Acorn
• 07613327294767: Carbide Round
• 07613327294750: Round, Extended
• 07613327294743: Carbide Round
• 07613327294736: Carbide Round
• 07613327294729: Match Head
• 07613327294712: Round Diamond, Extended