Multicare Platinum 8-004-0017

GUDID 15420045505926

Hologic, Inc.

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system
Primary Device ID15420045505926
NIH Device Record Key86f345a3-32f6-4d9f-b01b-dc211000224d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulticare Platinum
Version Model Number8-004-0017
Catalog Number8-004-0017
Company DUNS139534114
Company NameHologic, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS115420045505926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZHSystem, x-ray, mammographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-30

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