FDA.reportPublic FDA data

AccuBoost

Primary DI
00850306007544
Brand
AccuBoost
Company
ADVANCED RADIATION THERAPY, LLC
Model
450123-02
Catalog number
PM-PA-PA
Device description
Planmed Sophie - Paddle Assembly
Published
2019-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWJSystem, Applicator, Radionuclide, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWJSystem, Applicator, Radionuclide, ManualRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K863890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863890000MAMM-AIREAr Custom Medical Products, Ltd.1986-10-14KXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850306007544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850306007544008503060075448503060075440850306007544

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose brachytherapy system applicator, manualA general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to facilitate the creation of variable physical configurations or individual patient source placement configurations and includes general-purpose applicators such as hollow needles, tubes or catheters, ovoids or tandems.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(978)649-0007info@accuboost.com

Regulatory Flags#

DUNS number
193415051
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850306007605PreciseRT450729ART-PA-MSPRT2021-09-27
00850306007513AccuBoost450102-01ART-PA-32019-12-03
00850306007520AccuBoost450126ART-PT2019-12-03
00850306007537AccuBoost450123-01ART-PA-PA2019-12-03
00850306007551AccuBoost450123-03DM-PA-PA2019-12-03
00850306007568AccuBoost450128ART-PT-DM2019-12-03
00850306007575AccuBoost450129ART-PA-MSDM2019-12-03
00850306007582AccuBoost450125-01ART-PA-MSLP2019-12-03
00850306007599AccuBoost450125-02PM-PA-MSLP2019-12-03
00850306007407AccuBoost®450200-B0ART-SDO-4-B2018-09-05
00850306007414AccuBoost®450200-B1ART-SDO-5-B2018-09-05
00850306007421AccuBoost®450200-B2ART-SDO-6-B2018-09-05
00850306007438AccuBoost®450200-B3ART-SDO-7-B2018-09-05
00850306007445AccuBoost®450200-B4ART-SDO-8-B2018-09-05
00850306007452AccuBoost®450201-B1ART-DRO-5-B2018-09-05
00850306007469AccuBoost®450201-B2ART-DRO-6-B2018-09-05
00850306007476AccuBoost®450201-B3ART-DRO-7-B2018-09-05
00850306007483AccuBoost®450201-B4ART-DRO-8-B2018-09-05
00850306007490AccuBoost®450202-B1ART-NATD-SDO-45-B2018-09-05
00850306007506AccuBoost®450202-B2ART-NATD-SDO-53-B2018-09-05

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