TechCare Trauma

GUDID 03770024774047

MILVUE

Radiological PACS software
Primary Device ID03770024774047
NIH Device Record Key1aad06c0-7036-4fbb-9801-04916b1bd42e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTechCare Trauma
Version Model NumberV1.1.x
Company DUNS271298427
Company NameMILVUE
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS103770024774047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-08
Device Publish Date2025-03-31

Devices Manufactured by MILVUE

03770024774016 - SmartChest2025-04-08
03770024774047 - TechCare Trauma2025-04-08
03770024774047 - TechCare Trauma2025-04-08

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