FAXITRON CORE COREVISION5X10

GUDID 15420045514218

Hologic, Inc.

Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD 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 ID15420045514218
NIH Device Record Key951b5f34-13ee-4e08-8e85-4309a7860a96
Commercial Distribution StatusIn Commercial Distribution
Brand NameFAXITRON CORE
Version Model NumberCOREVISION 5X10
Catalog NumberCOREVISION5X10
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
GS115420045514218 [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 Date2021-07-23
Device Publish Date2021-07-15

On-Brand Devices [FAXITRON CORE]

15420045514218COREVISION 5X10
15420045516625Container with a base and a lid to hold surgical specimen sample for the purpose of x-ray imagin

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.