FDA.reportPublic FDA data

Clearsight Bolus

Primary DI
10850020486035
Brand
Clearsight Bolus
Company
CLEARSIGHT RT LLC
Model
B-03-20-01
Device description
Clearsight Bolus, 0.3cm water equivalent thickness, 0.34cm physical thickness, Clear, 40cm x 40cm, (3) units per package
Published
2022-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
IXGPhantom, Anthropomorphic, Radiographic
IYPPhantom, Anthropomorphic, Nuclear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXGPhantom, Anthropomorphic, RadiographicRadiology1
IYPPhantom, Anthropomorphic, NuclearRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850020486035PrimaryGS10
00850020486038Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002048603510850020486035
00850020486038008500204860388500204860380850020486038

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Centimeter
Width40Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store flat (not folded) in original packaging in a cool, dry environment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117523635
Device count
3
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850020486004Clearsight BolusB-03-18-012022-05-13
00850020486007Clearsight BolusB-03-18-012022-05-13
10850020486011Clearsight BolusB-05-18-012022-05-13
10850020486028Clearsight BolusB-11-18-012022-05-13
10850020486042Clearsight BolusB-05-20-012022-05-13
10850020486059Clearsight BolusB-11-20-012022-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812266030932Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030949Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030956Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030963Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030970Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030987Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030994Rando®Providus Holdings, Inc.IXG2024-07-11
00812266031007Rando®Providus Holdings, Inc.IXG2024-07-11
06977071930908MeicenGuangdong Meicen Medical Equipment Co., Ltd.IXG2024-06-21
00812266030758LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030765LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030772LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030789LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030796LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030802LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030697LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030703LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030710LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030727LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030734LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030741LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
09355529000033T1CMR Phantom (1.5T)RESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000064T1CMR Phantom (3.0T)RESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000071T2CMR PhantomRESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000088R2*/T2* PhantomRESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
00812266030673LiquiPhil™Providus Holdings, Inc.IXG2024-03-18
00812266030680LiquiPhil™Providus Holdings, Inc.IXG2024-03-18
EIBASR020010myQA® SRS Phantom CyberknifeIBA Dosimetry GmbHIXG2023-10-10
00850019946505Standard Imaging Lucy 3D QA PhantomSTANDARD IMAGING INC.IXG2023-06-22
00850019946512Standard Imaging MIMI PhantomSTANDARD IMAGING INC.IXG2023-06-22