Triton Canister System

GUDID 10859506006132

Box of 50 PN 11035

STRYKER CORPORATION

Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label Blood loss estimation canister insert/label

• Primary Device ID: 10859506006132
• NIH Device Record Key: 6a259ff3-a31f-4148-b398-6df56cfa2f59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triton Canister System
• Version Model Number: FG-12011
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10859506006132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142801

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-06-05
• Device Publish Date: 2018-06-25

On-Brand Devices [Triton Canister System]

• 10859506006132: Box of 50 PN 11035
• 10859506006101: Box of 50 PN 11033
• 10859506006040: Box of 50 PN 11026
• 10859506006033: Box of 50 PN 11015
• 10859506006019: Box of 50 PN 11004