EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG

GUDID 08800018407509

The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. It is intended for both adult and pediatric populations.

DRTECH Corporation

Indirect flat panel x-ray detector
Primary Device ID08800018407509
NIH Device Record Key4337ea24-5144-43a2-8876-9d27164b969e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
Version Model NumberEXPD 86P
Company DUNS689842626
Company NameDRTECH Corporation
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
GS108800018407509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-12-07
Device Publish Date2022-11-29

On-Brand Devices [EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG]

08800018407608The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG Digital X-ray detector is indicated for digital i
08800018407509The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG Digital X-ray detector is indicated for digital i
08800018407400The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG Digital X-ray detector is indicated for digital i
08800018407301The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG Digital X-ray detector is indicated for digital i

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