Brevera Breast Biopsy System BREV200

GUDID 15420045507753

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system

Primary Device ID	15420045507753
NIH Device Record Key	595cc337-5d07-403f-9e83-52033ea06401
Commercial Distribution Status	In Commercial Distribution
Brand Name	Brevera Breast Biopsy System
Version Model Number	BREV200
Catalog Number	BREV200
Company DUNS	018925968
Company Name	Hologic, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
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

Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius

Device Issuing Agency	Device ID
GS1	15420045507753 [Primary]

KNW	INSTRUMENT, BIOPSY

Steralize Prior To Use	false
Device Is Sterile	false