FDA.reportPublic FDA data

Bolus - Gel (w/o Film)

Primary DI
00628341930123
Brand
Bolus - Gel (w/o Film)
Company
CDR Systems Inc
Model
1
Catalog number
g-Bolus-B
Device description
Gel Bolus (without film)
Published
2019-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical
JADSystem, Therapeutic, X-Ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
JADSystem, Therapeutic, X-RayRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10628341930120PackageGS11In Commercial Distribution
00628341930123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062834193012010628341930120
00628341930123006283419301236283419301230628341930123

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy bolus, single-useA pliable, solid, non-sterile material (e.g., firm gel, paraffin, silicone) that has the properties of skin when irradiated and is intended to be applied to the skin to modify radiation dose at the skin surface or depth. It is available in various static thicknesses (e.g., 0.5 to 4.0 cm), which may be cut by the operator, to provide a reproducible radiation beam modifier for a prescribed dose depth during treatment of a particular site and disease. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
206950904
Device count
1
Lot or batch
true

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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