FDA.reportPublic FDA data

4.0-5.0 CM CT LUMEN MARKER SET

Primary DI
15420045505230
Brand
4.0-5.0 CM CT LUMEN MARKER SET
Company
Hologic, Inc.
Model
B90003
Catalog number
B90003
Device description
4.0-5.0 CM CT LUMEN MARKER SET
Published
2017-02-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAQSystem, applicator, radionuclide, remote-controlled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082264000CONTURA LUMEN MARKERSenorx, Inc.2008-09-12JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25420045505237PackageGS11Not in Commercial Distribution
15420045505230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2542004550523725420045505237
1542004550523015420045505230

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
018925968
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816389028081MAASTRO Rectal Applicator Set, ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-06-02
08717213014305NANucletron B.V.JAQ2019-02-02
08717213008472Shielded Cylindrical ApplicatorNucletron B.V.JAQ2018-07-11
08717213008892NANucletron B.V.JAQ2018-07-11
08717213008908NANucletron B.V.JAQ2018-07-11
08717213008915NANucletron B.V.JAQ2018-07-11
08717213009578Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009585Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009646Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213007772Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007796Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007826Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009660Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009677Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009691Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213010000Flexible Implant TubesNucletron B.V.JAQ2018-07-06
08717213010024Flexible Implant TubesNucletron B.V.JAQ2018-07-06
08717213009318Esophageal ApplicatorNucletron B.V.JAQ2018-06-27
08717213010666Flexible Implant TubesNucletron B.V.JAQ2018-06-27
08717213007765Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213009042Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213009059Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213013926Vaginal CT/MR ApplicatorNucletron B.V.JAQ2018-06-20
08717213008274MicroSelectron DigitalNucletron B.V.JAQ2018-06-14
08717213014022Standard CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014039Standard CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014145Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014152Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014169Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014206Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09