FDA.reportPublic FDA data

BrachyStar™, FastFill™

Primary DI
00801741075827
Brand
BrachyStar™, FastFill™
Company
Bard Brachytherapy, Inc.
Model
818201
Catalog number
818201
Device description
BrachyStar FastFill Seed Implant Needle with Antistatic Plastic Hub, Bone Wax Tip Insert and Lubricious Coating, 18g x 20cm Length
Published
2020-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741075824PackageGS110In Commercial Distribution
00801741075827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174107582410801741075824
00801741075827008017410758278017410758270801741075827

GMDN Terms#

Term, Definition table
TermDefinition
Brachytherapy injection needleA sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge18Gauge

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
185524860
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801741078122QuickLink™SPCRQC20SPCRQC202015-10-05
10801741075923BrachyStar™7182057182052020-09-21
10801741075947BrachyStar™9172059172052020-09-22
10801741075961BrachyStar™9182059182052020-09-22
10801741124119BrachyStar™, FastFill™8182058182052020-09-21
10801741184120SourceLink™703045070304502020-08-06
10801741184137SourceLink™703055070305502020-08-06
00801741075919BrachyStar™7182017182012020-09-21
00801741075933BrachyStar™9172019172012020-09-21
00801741075957BrachyStar™9182019182012020-09-22
10801741078061QuickLink™, SourceLink™70301QC570301QC52015-10-05
10801741078078QuickLink™, SourceLink™70301QC2070301QC202015-10-05
10801741078085QuickLink™, SourceLink™70302QC570302QC52015-10-05
10801741078092QuickLink™, SourceLink™70302QC1070302QC102015-10-05
10801741078108QuickLink™, SourceLink™70303QC1070303QC102015-10-05
10801741078115QuickLink™, SourceLink™70303QC2070303QC202015-10-05
10801741078139SourceLink™703012070301202015-10-05
10801741078146SourceLink™703020570302052015-10-05
10801741078153SourceLink™703031070303102015-10-05
00801741078194BrachySource™PS1251LPS1251L2015-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B16556440328083126176Implant NeedleLiberty Medical , Inc.IWJ2026-08-18
B16556450328083126173Single Leader Catheter with LuerLiberty Medical , Inc.IWJ2026-08-18
B16556500328083126172Small Prostate TemplateLiberty Medical , Inc.IWJ2026-08-18
B16557060328083126147Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B1655765032802312606Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16558000328043026121Small Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-08-18
B16559100328083126175ButtonsLiberty Medical , Inc.IWJ2026-08-18
B16560390328023126165Single Leader Catheter with LuerLiberty Medical , Inc.IWJ2026-08-18
B16570160328083126144Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16570170328083126159Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16570170328083126174Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B1657017032808312646Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16570550328083126017Gynecological TemplateLiberty Medical , Inc.IWJ2026-08-18
B16570940328083126166AdapterLiberty Medical , Inc.IWJ2026-08-18
B16570940328083126177AdapterLiberty Medical , Inc.IWJ2026-08-18
00841365121593Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-08-03
00841365121609Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-08-03
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.IWJ2026-07-23
B16556052032806302620Large Prostate TemplateLiberty Medical , Inc.IWJ2026-07-08
B16556510328063026080Medium Prostate TemplateLiberty Medical , Inc.IWJ2026-07-08
B16556630328063026137Intrauterine TandemLiberty Medical , Inc.IWJ2026-07-08
B16557060328060026140Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08
B16558000327103126049Small Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-07-08
B16558010328043026108Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-07-08
B16558100328103126034Small Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-07-08
B16559070328063026073ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16559080328063026059ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16559100328063026111ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16570160328063026139Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08
B1657060328063026115Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08