Triton Sponge- NUI Sensor bracket

GUDID 10859506006095

Pack of 5 PN 12008

STRYKER CORPORATION

Blood loss estimation application software

• Primary Device ID: 10859506006095
• NIH Device Record Key: 7bf81019-103b-43d1-b978-e19624f7c93d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triton Sponge- NUI Sensor bracket
• Version Model Number: FG 12007
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	10859506006095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163507

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: 4
• Public Version Date: 2024-06-05
• Device Publish Date: 2017-08-09

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