Faxitron

GUDID 00857069006005

Stationary digital specimen x-ray system with 5x10 cm imager intended for the examination of Core Biopsy excisions.

FAXITRON BIOPTICS, LLC

Stationary specimen x-ray system, digital
Primary Device ID00857069006005
NIH Device Record Key10cd2280-7955-4390-beda-b4f557cae82e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFaxitron
Version Model NumberCoreVision 5x10
Company DUNS968877360
Company NameFAXITRON BIOPTICS, LLC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857069006005 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-17

On-Brand Devices [Faxitron]

00857069006227Stationary Cabinet x-ray system with 15x15 cm imager used to provide two and three dimensional d
00857069006210Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excision
00857069006203Stationary digital specimen x-ray system with 6x15 cm imager intended for the verification of ha
00857069006197Stationary digital specimen x-ray system with 12x15 cm imager intended for the verification of h
00857069006180Stationary digital specimen x-ray system with 10x15 cm imager intended for the verification of h
00857069006050Stationary digital specimen x-ray system with 23x29cm imager intended for the examination of Cor
00857069006043Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excision
00857069006036Mobile digital specimen x-ray system with 10x10 cm imager for the examination of Biopsy excision
00857069006029Mobile digital specimen x-ray system with 10x12.5 cm imager for the examination of Biopsy excisi
00857069006012Mobile digital specimen x-ray system with 10x15 cm imager for the examination of Biopsy excision
00857069006005Stationary digital specimen x-ray system with 5x10 cm imager intended for the examination of Cor

Trademark Results [Faxitron]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FAXITRON
FAXITRON
88230332 not registered Live/Pending
Faxitron Bioptics, LLC
2018-12-14
FAXITRON
FAXITRON
74102636 1657643 Dead/Cancelled
Faxitron, Inc.
1990-10-01
FAXITRON
FAXITRON
72255525 0837529 Live/Registered
FIELD EMISSION CORPORATION
1966-09-30

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