Eviva

GUDID 15420045509917

Hologic, Inc.

Mammographic stereotactic biopsy system

• Primary Device ID: 15420045509917
• NIH Device Record Key: d1cbc36c-d4b8-4178-8e90-7c65d720fb78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eviva
• Version Model Number: Eviva_STX_Kit_Opdima
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045509917 [Primary]

FDA Product Code

• PXP: Breast biopsy / localization tray

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: 2019-04-10
• Device Publish Date: 2019-04-02

On-Brand Devices [Eviva]

• 25420045509945: EVIVA_BUSHING_GE
• 15420045509962: EVIVA_CALIBRATE_13CM
• 15420045509948: EVIVA_BUSHING_GE
• 15420045509931: EVIVA_STX_KIT_GIOTTO
• 15420045509924: EVIVA_STX_KIT_INSPIR
• 15420045509917: Eviva_STX_Kit_Opdima
• 15420045509900: Eviva_STX_Kit_Affirm
• 15420045509894: Eviva_STX_KIT_GEL-V
• 15420045509887: Eviva_STX_KIT_GEVER
• 15420045509870: Eviva_STX_KIT_GELAT
• 15420045509863: Eviva_STX_KIT_SLOC
• 15420045509856: Eviva_STX_KIT_MTEST
• 15420045509771: FAB-06337
• 15420045509764: EVIVA_NG_HOLDER
• 15420045509757: EVIVA_STYLET_BRACKET
• 15420045509740: EVIVA_ADAPTER_MTEST
• 15420045509733: Eviva_STX_KIT_13cm
• 15420045509726: EVIVA_ADAPTER