FDA.reportPublic FDA data

Positioning Aids

Primary DI
10628341930236
Brand
Positioning Aids
Company
CDR Systems Inc
Model
1
Catalog number
THS03
Device description
Cranial Head Support
Published
2019-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K122888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122888000CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEMCdr Systems, Inc.2013-04-30IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10628341930236PackageGS11In Commercial Distribution
00628341930239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062834193023610628341930236
00628341930239006283419302396283419302390628341930239

GMDN Terms#

Term, Definition table
TermDefinition
Radiological headrestA non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device.

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
10628341930373Thermoplastic12023-12-31
10628341930380Thermoplastic12023-12-31
00628341930482Freedom1AP22023-08-08
00628341930499Freedom1AP2-K2023-08-08
00628341930468TBI1TBI202023-03-08
10628341930465TBI1TBI202023-03-08
00628341930444Freedom1LBST2023-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21
00850065937144eMotusEMPNIA INC.IYE2026-09-21
00850065937151eMotusEMPNIA INC.IYE2026-09-21
00850065937168eMotusEMPNIA INC.IYE2026-09-21
00850065937175eMotusEMPNIA INC.IYE2026-09-21
00850065937182eMotusEMPNIA INC.IYE2026-09-21
00850065937199eMotusEMPNIA INC.IYE2026-09-21
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