Brevera Breast Biopsy System BREVTF01

GUDID 15420045507791

Mammographic stereotactic biopsy system

Primary Device ID	15420045507791
NIH Device Record Key	818b34ca-0d8b-442b-92db-33462ca18ea3
Commercial Distribution Status	In Commercial Distribution
Brand Name	Brevera Breast Biopsy System
Version Model Number	BREVTF01
Catalog Number	BREVTF01
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

Device Issuing Agency	Device ID
GS1	15420045507791 [Primary]
GS1	25420045507798 [Package] Package: BOX [5 Units] In Commercial Distribution
GS1	35420045507795 [Package] Contains: 25420045507798 Package: BOX [5 Units] In Commercial Distribution

KNW	INSTRUMENT, BIOPSY

Steralize Prior To Use	true
Device Is Sterile	true

[15420045507791]

Radiation Sterilization

[15420045507791]

Radiation Sterilization