FDA.reportPublic FDA data

QuickLink™

Primary DI
00801741079283
Brand
QuickLink™
Company
Bard Brachytherapy, Inc.
Model
70310SGA4
Catalog number
70310SGA4
Device description
QuickLink™ Relay System BrachyStar™ Relay Clipped
Published
2016-09-19
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741079283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741079283008017410792838017410792830801741079283

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
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
185524860
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
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

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Primary DI, Brand, Company table
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