Selenia FFDM

GUDID 15420045507876

Hologic, Inc.

Stationary mammographic x-ray system, digital
Primary Device ID15420045507876
NIH Device Record Key95930583-9f5f-4a9c-818a-5cca2da06652
Commercial Distribution StatusIn Commercial Distribution
Brand NameSelenia FFDM
Version Model Number3-000-1528
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045507876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUEFull field digital,system,x-ray,mammographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-16

On-Brand Devices [Selenia FFDM]

154200455079204-000-0308
15420045507913ASY-05468
154200455078904-000-0144
154200455078833-000-4617
154200455078763-000-1528
15420045507715FAB-00752
15420045507708FAB-00609
154200455076924-000-0293
154200455076853-535-0087
154200455076783-535-0012
15420045507586FAB-00754
15420045507579FAB-00610
15420045507562FAB-00608
154200455075555-000-0073
154200455075485-000-0072
15420045506060ASY-07973
15420045506053ASY-06758
15420045506046ASY-06755
15420045506039ASY-06754
15420045506022ASY-06753
15420045506015ASY-06717
15420045506008ASY-06716
15420045505995ASY-06715
15420045505988ASY-06714
15420045505971ASY-01656
15420045505964ASY-01427
15420045505957ASY-01366
15420045505940ASY-00676
15420045505933ASY-00834

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