Brevera Breast Biopsy System BREVTF12

GUDID 15420045513778

Hologic, Inc.

General tissue specimen container IVD, normal saline General tissue specimen container IVD, normal saline General tissue specimen container IVD, normal saline General tissue specimen container IVD, normal saline General tissue specimen container IVD, normal saline General tissue specimen container IVD, normal saline General tissue specimen container IVD, normal saline General tissue specimen container IVD, normal saline General tissue specimen container IVD, normal saline General tissue specimen container IVD, normal saline General tissue specimen container IVD, normal saline General tissue specimen container IVD, normal saline General tissue specimen container IVD, normal saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline General tissue specimen container IVD, fixative/saline

• Primary Device ID: 15420045513778
• NIH Device Record Key: 59e70531-8484-4503-adb4-1d0b53b6169f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brevera Breast Biopsy System
• Version Model Number: BREVTF12
• Catalog Number: BREVTF12
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• 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: 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

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045513778 [Primary]
GS1	25420045513775 [Package]; Package: BOX [4 Units]; In Commercial Distribution
GS1	35420045513772 [Package]; Contains: 25420045513775; Package: BOX [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163052

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

[15420045513778]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-09
• Device Publish Date: 2020-09-01

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