Faxitron OR

GUDID 00857069006265

FAXITRON BIOPTICS, LLC

Specimen x-ray system IVD
Primary Device ID00857069006265
NIH Device Record Key1c1e3229-44b7-41f5-9232-e95c69e26454
Commercial Distribution StatusIn Commercial Distribution
Brand NameFaxitron OR
Version Model NumberBioVision 10x15
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
GS100857069006265 [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 Date2020-01-22
Device Publish Date2019-07-02

Devices Manufactured by FAXITRON BIOPTICS, LLC

00857069006265 - Faxitron OR2020-01-22
00857069006265 - Faxitron OR2020-01-22
00857069006012 - Faxitron2020-01-22 Mobile digital specimen x-ray system with 10x15 cm imager for the examination of Biopsy excisions.
00857069006029 - Faxitron2020-01-22 Mobile digital specimen x-ray system with 10x12.5 cm imager for the examination of Biopsy excisions.
00857069006036 - Faxitron2020-01-22 Mobile digital specimen x-ray system with 10x10 cm imager for the examination of Biopsy excisions.
00857069006043 - Faxitron2020-01-22 Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excisions.
00857069006210 - Faxitron2020-01-22 Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excisions.
00857069006272 - Faxitron Core2019-07-10
00857069006289 - Faxitron Path2019-07-10

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