BSD3543W Digital Flat Panel X-ray Detector

GUDID 08800069500051

bontech Inc

Indirect flat panel x-ray detector
Primary Device ID08800069500051
NIH Device Record Key1ec4091c-63a0-4ae3-bbc5-3f35a6da93f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBSD3543W Digital Flat Panel X-ray Detector
Version Model NumberBT-DA22W
Company DUNS689050426
Company Namebontech Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108800069500051 [Primary]

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-19
Device Publish Date2025-09-11

On-Brand Devices [BSD3543W Digital Flat Panel X-ray Detector]

08800069500068BT-DB22W
08800069500051BT-DA22W

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