EXSYS DEXi

GUDID 08800018425800

DRTECH Corporation

Stationary basic diagnostic x-ray system, digital
Primary Device ID08800018425800
NIH Device Record Key01f03dad-044a-42e2-b118-63d893c3616a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXSYS DEXi
Version Model NumberEXSYS DEXi-D402P-FRA
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800018425800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, X-Ray, Stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-02
Device Publish Date2025-03-25

On-Brand Devices [EXSYS DEXi]

08800018425909EXSYS DEXi-D503T-FRA
08800018425800EXSYS DEXi-D402P-FRA
08800018425701EXSYS DEXi-D401P-FRA
08800018425602EXSYS DEXi-D402S-FRA
08800018425503EXSYS DEXi-D401S-FRA
08800018422403EXSYS DEXi-A503T-FRM
08800018422304EXSYS DEXi-A402P-FRM
08800018422205EXSYS DEXi-A401P-FRM
08800018422106EXSYS DEXi-A402S-FRM
08800018422007EXSYS DEXi-A401S-FRM
08800018421901EXSYS DEXi-D503T-FRM
08800018421802EXSYS DEXi-D402P-FRM
08800018421703EXSYS DEXi-D401P-FRM
08800018421604EXSYS DEXi-D402S-FRM
08800018421505EXSYS DEXi-D401S-FRM

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