Brevera Breast Biopsy System BREVSTXKITM

GUDID 35420045507832

Hologic, Inc.

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system

• Primary Device ID: 35420045507832
• NIH Device Record Key: fe08e87f-20a1-46f0-8beb-f60197788aa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brevera Breast Biopsy System
• Version Model Number: BREVSTXKITM
• Catalog Number: BREVSTXKITM
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	35420045507832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163052

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

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: 2018-09-28
• Device Publish Date: 2018-08-28

On-Brand Devices [Brevera Breast Biopsy System]

• 35420045507856: BREVSTXKITG
• 35420045507832: BREVSTXKITM
• 35420045507801: BREVSTXKIT
• 15420045507852: BREVADPTRG
• 15420045507838: BREVADPTRM
• 15420045507807: BREVADPTR
• 15420045507791: BREVTF01
• 15420045507784: BREVTF12
• 15420045507777: BREV09
• 15420045507760: BREVDRV
• 15420045507753: BREV200
• 15420045507517: BREV100
• 15420045507821: BREVSTYLBRKT
• 15420045512863: BREVDISP09
• 15420045513778: BREVTF12
• 15420045513761: BREVTF01
• 15420045515161: Reusable Driver