TBI TBI20

GUDID 10628341930465

TBI Positioning System With Spoiler

CDR Systems Inc

Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system
Primary Device ID10628341930465
NIH Device Record Keyaa2d4626-c99f-489a-9ed2-4d8f5b120bfc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTBI
Version Model Number1
Catalog NumberTBI20
Company DUNS206950904
Company NameCDR Systems 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 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

Customer Support Contacts

Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca
Phone403-850-7035
Emailinfo@cdrsys.ca

Device Identifiers

Device Issuing AgencyDevice ID
GS100628341930468 [Primary]
GS110628341930465 [Package]
Contains: 00628341930468
Package: [1 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-16
Device Publish Date2023-03-08

Devices Manufactured by CDR Systems Inc

10628341930502 - EQUILIBRIUM2024-02-02 EQUILIBRIUM Rotating Overlay System
10628341930373 - Thermoplastic2024-01-08 Thermoplastic Immobilization Materials
10628341930380 - Thermoplastic2024-01-08 Thermoplastic Immobilization Mask
10628341930465 - TBI2023-03-16TBI Positioning System With Spoiler
10628341930465 - TBI2023-03-16 TBI Positioning System With Spoiler
10628341930441 - Freedom2023-03-03 Freedom S-Type Overlay
10628341930458 - Freedom2023-03-03 Freedom S-Type Overlay (MR Safe)
00628341930406 - Solid Bolus2020-05-25 Solid Bolus
10628341930427 - Freedom2020-05-25 Freedom Prone Head & Neck Immobilization (MR Conditional)
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