FDA.reportPublic FDA data

Thermoplastic

Primary DI
10628341930373
Brand
Thermoplastic
Company
CDR Systems Inc
Model
1
Device description
Thermoplastic Immobilization Materials
Published
2023-12-31
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10628341930373PackageGS11Not in Commercial Distribution
00628341930376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062834193037310628341930373
00628341930376006283419303766283419303760628341930376

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning thermoplastic mould materialA thermoplastic material used to create moulds of a patient's body. It is commonly supplied as sheets or meshes of thermoplastic material that have been coated with polyurethane for ease of handling and positioning. Most of these materials are softened by heating in hot water and while softened, are moulded around the patient's anatomy. When cooled, it hardens to form a custom-made mould or cast of that part of the body. After the moulding process is complete, it is typically attached to a board, frame, or another patient positioning system (PPS) or immobilization device. After application, this device cannot be reused (i.e., remoulded).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
403-850-7035info@cdrsys.ca

Regulatory Flags#

DUNS number
206950904
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628341931915Instaform1IF-012026-08-17
00628341930512Extremity Lock1EXT-24STD2024-12-11
00628341930529Extremity Lock1EXT-24STD-K2025-01-21
00628341930352Freedom1PLUS2019-12-31
00628341930369Freedom1PLUS-K2019-12-31
00628341930413Solid Bolus1S-Bolus2025-01-21
10628341930410Solid Bolus1S-Bolus2025-01-21
10628341930526Extremity Lock1EB-24STD-K2025-01-21
10628341930519Extremity Lock1EB-24STD2024-12-11
00628341930505EQUILIBRIUM12024-01-25
10628341930502EQUILIBRIUM12024-01-25
00628341930376Thermoplastic12023-12-31
00628341930383Thermoplastic12023-12-31
10628341930380Thermoplastic12023-12-31
00628341930482Freedom1AP22023-08-08
00628341930499Freedom1AP2-K2023-08-08
00628341930468TBI1TBI202023-03-08
10628341930465TBI1TBI202023-03-08
00628341930444Freedom1LBST2023-02-23
00628341930451Freedom1LBST-K2023-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850065937052eMotusEMPNIA INC.IYE2026-09-21
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00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
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00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
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00850065937151eMotusEMPNIA INC.IYE2026-09-21
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00850065937205eMotusEMPNIA INC.IYE2026-09-21
00850065937212eMotusEMPNIA INC.IYE2026-09-21
00850065937229eMotusEMPNIA INC.IYE2026-09-21
00850065937236eMotusEMPNIA INC.IYE2026-09-21
00850065937243eMotusEMPNIA INC.IYE2026-09-21
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