Quantib Prostate

GUDID 08719689791131

Quantib B.V.

Radiology DICOM image processing application software
Primary Device ID08719689791131
NIH Device Record Key7eb64ec6-20f5-4059-86b1-bb35d7c25310
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantib Prostate
Version Model Number1.2
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
GS108719689791131 [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 Date2021-04-21
Device Publish Date2021-04-13

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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