Brevera Breast Biopsy System BREVTF12

GUDID 15420045507784

Hologic, Inc.

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system
Primary Device ID15420045507784
NIH Device Record Key5d7f5f53-259d-4acb-98a2-2006bc5014e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrevera Breast Biopsy System
Version Model NumberBREVTF12
Catalog NumberBREVTF12
Company DUNS018925968
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS115420045507784 [Primary]
GS125420045507781 [Package]
Package: BOX [5 Units]
In Commercial Distribution
GS135420045507788 [Package]
Contains: 25420045507781
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

[15420045507784]

Radiation Sterilization


[15420045507784]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-07

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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