FDA.reportPublic FDA data

QuickLink™

Primary DI
10801741078122
Brand
QuickLink™
Company
Bard Brachytherapy, Inc.
Model
SPCRQC20
Catalog number
SPCRQC20
Device description
QuickLink™ Cartridge 5.5 mm Spacer
Published
2015-10-05
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
KXKSource, brachytherapy, radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWJSystem, Applicator, Radionuclide, ManualRadiology1
KXKSource, Brachytherapy, RadionuclideRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741078122PrimaryGS10
00801741078125Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174107812210801741078122
00801741078125008017410781258017410781250801741078125

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)977-6733medical.services@crbard.com

Regulatory Flags#

DUNS number
185524860
Device count
20
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00801741075827BrachyStar™, FastFill™8182018182012020-09-21
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
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B1655662032805302615Intrauterine TandemLiberty Medical , Inc.IWJ2026-06-01
B16558010327123126103Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B16558010328010026067Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B165580203270931260031Large Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B16558110328022826066Medium Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-06-01
B16559050328053126091ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559060328053026074ButtonsLiberty Medical , Inc.IWJ2026-06-01
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B16570160328053126101Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B16570170328053126102Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B16570940328053126107AdapterLiberty Medical , Inc.IWJ2026-06-01
00841365121579Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-29
M936IIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
M936PDIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
B201CGSG140Clear Guide SteriGRIDCLEAR GUIDE MEDICAL, INC.IWJ2026-05-11
B165565003280430252241Small Prostate TemplateLiberty Medical , Inc.IWJ2026-05-01
B16556510328043026077Medium Prostate TemplateLiberty Medical , Inc.IWJ2026-05-01
B165576403280430260101Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16557640328043026081Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16557650328040025244Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16559060328043026048ButtonsLiberty Medical , Inc.IWJ2026-05-01
B16559070328043025007ButtonsLiberty Medical , Inc.IWJ2026-05-01
B16570160328043026056Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16570170328043026057Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16556320328033123181Flexi-NeedleLiberty Medical , Inc.IWJ2026-03-26
B16556470328033126031Catheter CapsLiberty Medical , Inc.IWJ2026-03-26
B16557060328033126014Flexi-NeedleLiberty Medical , Inc.IWJ2026-03-26