Brevera Breast Biopsy System BREV09

GUDID 15420045507777

Hologic, Inc.

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system
Primary Device ID15420045507777
NIH Device Record Keybeb97b43-9f19-4c1a-be72-872125a828ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrevera Breast Biopsy System
Version Model NumberBREV09
Catalog NumberBREV09
Company DUNS018925968
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045507777 [Primary]
GS135420045507771 [Package]
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWINSTRUMENT, BIOPSY

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[15420045507777]

Radiation Sterilization


[15420045507777]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-21
Device Publish Date2018-08-28

On-Brand Devices [Brevera Breast Biopsy System]

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

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