FAXITRON MAMMOTOME

GUDID 15420045516649

Container with a base and a lid to hold surgical specimen sample for the purpose of x-ray imaging that sample

Hologic, Inc.

Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD
Primary Device ID15420045516649
NIH Device Record Key230159b3-546a-4d07-8101-2a9f019b4d15
Commercial Distribution StatusIn Commercial Distribution
Brand NameFAXITRON MAMMOTOME
Version Model Number120-807604
Company DUNS139534114
Company NameHologic, Inc.
Device Count25
DM Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045516649 [Unit of Use]
GS125420045516646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWPCabinet, x-ray system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-19
Device Publish Date2023-04-11

Devices Manufactured by Hologic, Inc.

15420045510548 - 3Dimensions2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
15420045510555 - 3Dimensions2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
15420045510562 - 3Dimensions2024-07-08 Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray image
15420045510579 - 3Dimensions2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
15420045510586 - 3Dimensions2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
15420045510593 - 3Dimensions2024-07-08 Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray image
15420045510760 - Selenia Dimensions2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
15420045511422 - Panther Fusion®2024-06-18 Cytomegalovirus (CMV) Primers ASR.
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