FiberTEMP Fiber Optic Surface Temperature Sensor 989803152801

GUDID 00884838004979

INVIVO CORPORATION

Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered Continuous electronic patient thermometer, battery-powered

• Primary Device ID: 00884838004979
• NIH Device Record Key: 11865d23-d9b1-450b-8c42-b0ac0707abfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FiberTEMP Fiber Optic Surface Temperature Sensor
• Version Model Number: 989803152801
• Catalog Number: 989803152801
• Company DUNS: 013649151
• Company Name: INVIVO CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838004979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040915

FDA Product Code

• FLL: Thermometer, electronic, clinical

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: 2019-10-08
• Device Publish Date: 2019-09-30

Devices Manufactured by INVIVO CORPORATION

• 00884838103740 - Sentinelle: 2023-03-06 Sentinelle, Biopsy Grid
• 00884838115279 - Invivo: 2022-11-30 Kit, Enhanced Access, Bilateral Upgrade consists of Fiducial Marker Block; 3 Grid Plates Enhanced Access-Lateral; 3 Grid Plates
• 00884838115309 - Invivo: 2022-11-30 dS Breast 16 Biopsy Pack, 1.5T contains - 4 Lateral Grids Upper dS Breast 16Ch I/T; 4 Medial Grids dS Breast 16CH I/T; MRI Needl
• 00884838115255 - Invivo: 2022-11-28 BREAST 7 BIOPSY PACK 1.5T contains - 3 LBS M-L Grid Immobilization Plates; 3 LBS M-L Pillar Immobilization Plates Sterilized; M
• 00884838115507 - Sentinelle: 2022-10-24 DS Sentinelle Breast 16CH Coil Kit, 1.5T Consists of 1CH Left and Right Lateral Coils and Medial Plug with box of 10 Sentinelle
• 00884838115514 - Sentinelle: 2022-10-24 DS Sentinelle Breast coil, Biopsy Kit 3.0T Consists of 1CH Left and Right Lateral Coils and Medial Plug with box of 10 Sentinell
• 00884838105195 - Sentinelle: 2022-10-20 dS 3.0T 4CH Lateral Left
• 00884838105201 - Sentinelle: 2022-10-20 dS 3.0T 4CH Lateral Right