Personalized PseudoPatient™ PV PFL-02PV

GUDID 00860001523218

Personalized PseudoPatient™ PV FL

RTSAFE, INC.

Custom-made organ/bone anatomy model
Primary Device ID00860001523218
NIH Device Record Key8fe98bd2-848c-4f95-ac21-152a9e87efbc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePersonalized PseudoPatient™ PV
Version Model NumberPFL-02PV
Catalog NumberPFL-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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone210-542-5822
Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001523218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

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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