Quantib Prostate

GUDID 08719689791223

No description.

Quantib B.V.

Radiology DICOM image processing application software
Primary Device ID08719689791223
NIH Device Record Key493169fb-c8f7-4cd8-ad3f-5f5528eaa434
Commercial Distribution Discontinuation2023-05-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameQuantib Prostate
Version Model Number3.0
Company DUNS490216247
Company NameQuantib B.V.
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
GS108719689791223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-18
Device Publish Date2023-05-10

On-Brand Devices [Quantib Prostate]

087196897910561.0
087196897911171.1
087196897911311.2
087196897911551.3
087196897911862.0
087196897912092.1
08719689791223No description.
08719689791230No description.
08719689791278No description.
087196897912923.3

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