FDA.reportPublic FDA data

Action®

Primary DI
00089904000095
Brand
Action®
Company
ACTION PRODUCTS, INC.
Model
Bolx I
Catalog number
31151
Published
2016-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JADSystem, Therapeutic, X-Ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JADSystem, Therapeutic, X-RayRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K811528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811528000RADIATION BOLUSAction Products, Inc.1981-07-10JAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00089904000095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904000095000899040000950899040000950089904000095

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy bolus, reusableA 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 reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Minimal UV light exposure
Special Storage Condition, Specify00Store flat
Special Storage Condition, Specify00Store in a clean, dry environment

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
067543058
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00089904002297Action®Mattress Overlay6400H2021-02-03
00089904002310Action®Mattress Overlay6405H2021-02-03
00089904002280Action®Mattress Overlay64002021-01-21
00089904002303Action®Mattress Overlay64052021-01-21
00089904011374Action®OR Table Replacement Pad70915A2026-01-08
00089904011381Action®OR Table Replacement Pad779102026-01-08
00089904011398Action®OR Table Replacement Pad55915C2026-01-08
00089904011367Action®OR Table Replacement Pad75910D2025-11-18
00089904000958Action®Arm Pad403122021-01-11
00089904011350Action®OR Table Replacement Pad57140C2025-08-28
00089904011343Action®OR Table Replacement Pad721402025-01-06
00089904011336Action®OR Table Replacement Pad57310C2024-09-10
00089904009531Action®Disposable Cover40616DC2021-01-14
00089904009548Action®Disposable Cover40617DC2021-01-14
00089904009555Action®Disposable Cover40618DC2021-01-14
00089904009562Action®Disposable Cover40619DC2021-01-14
00089904009579Action®Disposable Cover40620DC2021-01-14
00089904009586Action®Disposable Cover40621DC2021-01-14
00089904000231Action®Disposable Cover40102I2021-01-14
00089904000422Action®Disposable Cover401022021-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049539105509INTRABEAM Spherical Sizer SetCarl Zeiss Meditec AGJAD2025-06-20
04049539105516INTRABEAM SMART Spherical ApplicatorCarl Zeiss Meditec AGJAD2025-05-14
04049539105523INTRABEAM SMART Spherical Applicator Carl Zeiss Meditec AGJAD2025-05-14
04049539105530INTRABEAM SMART Spherical Applicator Carl Zeiss Meditec AGJAD2025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)Carl Zeiss Meditec AGJAD2025-05-14
04049539105554INTRABEAM SMART Spherical Applicator (35mm)Carl Zeiss Meditec AGJAD2025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)Carl Zeiss Meditec AGJAD2025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)Carl Zeiss Meditec AGJAD2025-05-14
04049539064080INTRABEAMCarl Zeiss Meditec AGJAD2025-04-01
04049539066503INTRABEAM SMART StandCarl Zeiss Meditec AGJAD2025-04-01
05060494200084X80 / RADiant / PhotoElectric Therapy SystemXSTRAHL LIMITEDJAD2024-05-08
08717213057760EsteyaNucletron B.V.JAD2022-08-16
00089904010728Action®ACTION PRODUCTS, INC.JAD2021-03-23
00628341930116Bolus - Gel (film)CDR Systems IncJAD2019-12-31
00628341930123Bolus - Gel (w/o Film)CDR Systems IncJAD2019-12-31
00850008977008Balloon ApplicatorIcad, Inc.JAD2019-11-05
00850008977015Balloon ApplicatorIcad, Inc.JAD2019-11-05
00858012005984Balloon ApplicatorIcad, Inc.JAD2019-11-05
00858012005991Balloon ApplicatorIcad, Inc.JAD2019-11-05
10850002237013SensusSENSUS HEALTHCARE, INC.JAD2018-12-12
10850002237020SensusSENSUS HEALTHCARE, INC.JAD2018-12-12
10850002237037SensusSENSUS HEALTHCARE, INC.JAD2018-12-12
00089904008398Action®ACTION PRODUCTS, INC.JAD2018-07-06
08717213038820EsteyaNucletron B.V.JAD2018-06-12
08717213038837EsteyaNucletron B.V.JAD2018-06-12
08717213038844EsteyaNucletron B.V.JAD2018-06-12
00089904008077Action®ACTION PRODUCTS, INC.JAD2018-06-11
00089904007971Action®ACTION PRODUCTS, INC.JAD2018-04-06
00089904007964Action®ACTION PRODUCTS, INC.JAD2018-03-12
00089904007810Action®ACTION PRODUCTS, INC.JAD2018-01-29