FDA.report

4-5 CM CONTURA MLB CATHETER w/TRI INTRODUCER

Primary DI
15420045505148
Brand
4-5 CM CONTURA MLB CATHETER w/TRI INTRODUCER
Company
Hologic, Inc.
Model
B01245
Catalog number
B01245
Published
2017-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JAQSystem, applicator, radionuclide, remote-controlled

Product Code Classifications

CodeDeviceSpecialtyClass
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
25420045505145PackageGS11Not in Commercial Distribution
15420045505148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2542004550514525420045505145
1542004550514815420045505148

GMDN Terms

TermDefinition
Breast brachytherapy system applicator, remote-afterloadingA sterile, remote-afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the breast. It is typically designed for temporary implantation within the breast and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources. Included are various types of applicators such as hollow needles, tubes, or catheters, and their associated components. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature025 Degrees Celsius

Sterilization Methods

Method
Radiation Sterilization

Contacts

PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags

DUNS number
018925968
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
15420045518131Selenia® Dimensions®ASY-10775-2DASY-10775-2D2026-03-12
15420045518148Selenia® Dimensions®ASY-10775-3DASY-10775-3D2026-03-12
15420045518155Selenia® Dimensions®ASY-10775-2D-UPSASY-10775-2D-UPS2026-03-12
15420045518162Selenia® Dimensions®ASY-10775-3D-UPSASY-10775-3D-UPS2026-03-12
15420045518179Selenia® Dimensions®ASY-10775-2D-CNASY-10775-2D-CN2026-03-12
15420045518186Selenia® Dimensions®ASY-08483-2DASY-08483-2D2026-03-12
15420045518193Selenia® Dimensions®ASY-10775-3D-CNASY-10775-3D-CN2026-03-12
15420045518216Selenia® Dimensions®ASY-08483-3DASY-08483-3D2026-03-12
15420045518223Selenia® Dimensions®ASY-08483-3D-CNASY-08483-3D-CN2026-03-12
15420045518230Selenia® Dimensions®ASY-08483-2D-CNASY-08483-2D-CN2026-03-12
15420045518247Affirm Prone Biopsy SystemPBX-SYS-AFFIRM-3D-CNPBX-SYS-AFFIRM-3D-CN2026-03-12
15420045518261Affirm Prone Biopsy SystemPBX-SYS-AFFIRM-2D-CNPBX-SYS-AFFIRM-2D-CN2026-03-12
15420045518278Affirm Prone Biopsy SystemASY-06886-CNASY-06886-CN2026-03-12
15420045518285Affirm Prone Biopsy SystemASY-09175-CNASY-09175-CN2026-03-12
15420045518292Affirm Prone Biopsy SystemASY-08832-CNASY-08832-CN2026-03-12
15420045516236EnvisionASY-14621ASY-146212025-11-13
15420045516243EnvisionASY-14622ASY-146222025-11-13
15420045516250EnvisionASY-14623ASY-146232025-11-13
15420045516267EnvisionASY-14624ASY-146242025-11-13
15420045516274EnvisionASY-14625ASY-146252025-11-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00816389020191Applicator and Dilator for Proctoscope ø26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389020207Applicator and Dilator for Proctoscope ø30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028098Applicator ø 20 mm, for Proctoscope ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028104Proctoscope ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028111Dilator for Proctoscope ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028128Illumination Adapter for Proctoscope ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028135Fixation ScrewVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028142MAASTRO Rectal Applicator Set, ø 30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028159Applicator ø 24 mm, for Proctoscope ø 30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028166Proctoscope ø 30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028173Dilator for Proctoscope ø 30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028180Illumination Adapter for Proctoscope ø 30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389028999Targeting Window Applicator ø 20 mm, for Proctoscope ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00816389029002Targeting Window Applicator ø 24 mm, for Proctoscope ø 30 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-05-26
00810563022629Guiding tube 60 degrees ring for central needleVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028937Guided Aarhus Applicator SetVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028944Guided Aarhus vaginal template 60 degrees,ø 28 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028951Guided Aarhus vaginal template 60 degrees, ø 32 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028968Guided Aarhus vaginal template 60 degrees, ø 36 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028975Guide tube collector for up to 7 needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00816389028982Guide tube collector for up to 11 needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2025-11-25
00810563022957Titanium Flexible Geometry FSD Applicator SetVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-22
00810563022995Ovoid pair, mini ø 16 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-22
00810563023008Ovoid mini Ø16 mm LeftVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-22
00810563023015Ovoid mini Ø16 mm RightVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-22
00810563023022Titanium Allen wrenchVarian Medical Systems Deutschland GmbHJAQ2025-05-21
00816389027961Interstitial mini ovoid pair, with fixation for guide tubesVarian Medical Systems Deutschland GmbHJAQ2025-05-21
00816389027978Interstitial ovoid pair for 20mm spread, with fixation for guide tubesVarian Medical Systems Deutschland GmbHJAQ2025-05-21
00816389027985Interstitial ovoid pair for 25mm spread, with fixation for guide tubesVarian Medical Systems Deutschland GmbHJAQ2025-05-21
00816389027992Interstitial ovoid pair for 30mm spread, with fixation for guide tubesVarian Medical Systems Deutschland GmbHJAQ2025-05-21