Personalized PseudoPatient™ PV

Primary DI
00860001523218
Brand
Personalized PseudoPatient™ PV
Company
RTSAFE, INC.
Model
PFL-02PV
Catalog number
PFL-02PV
Device description
Personalized PseudoPatient™ PV FL
Published
2019-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180697000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180697000Pseudo-PatientRtsafe, Inc.2018-07-10IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001523218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001523218008600015232188600015232180860001523218

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy modelA model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius24 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
210-542-5822tpapanikolaou@rt-safe.com

Regulatory Flags#

DUNS number
080928779
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001523201Personalized PseudoPatient™ PVPIC-02PVPIC-02PV2019-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850065937250eMotusEMPNIA INC.IYE2026-09-21
00850065937267eMotusEMPNIA INC.IYE2026-09-21
00850065937274eMotusEMPNIA INC.IYE2026-09-21
00850065937298eMotusEMPNIA INC.IYE2026-09-21
00850065937304eMotusEMPNIA INC.IYE2026-09-21