Personalized PseudoPatient™ PV PIC-02PV

GUDID 00860001523201

Personalized PseudoPatient™ PV IC


Custom-made organ/bone anatomy model
Primary Device ID00860001523201
NIH Device Record Keybb1718de-dbe6-4488-a65b-15dfec5d4de4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePersonalized PseudoPatient™ PV
Version Model NumberPIC-02PV
Catalog NumberPIC-02PV
Company DUNS080928779
Company NameRTSAFE, INC.
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 Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001523201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical


Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-27
Device Publish Date2019-05-31

On-Brand Devices [Personalized PseudoPatient™ PV]

00860001523218Personalized PseudoPatient™ PV FL
00860001523201Personalized PseudoPatient™ PV IC

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