FDA.reportPublic FDA data

Indexed Quick Connect, channel 1, reusable

Primary DI
00816389021174
Brand
Indexed Quick Connect, channel 1, reusable
Company
Varian Medical Systems Deutschland GmbH
Model
AL12500001
Catalog number
AL12500001
Published
2016-09-22
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
false

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
K061582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061582000VARISOURCE 200 HDR AFTERLOADERVarian Medical Systems, Inc.2006-07-25JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816389021174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816389021174008163890211748163890211740816389021174

GMDN Terms#

Term, Definition table
TermDefinition
Brachytherapy system remote afterloading source transfer tubeA tube or hose-like catheter with connectors at both ends used to interface the brachytherapy applicator to the remote afterloading system. The transfer tube, when attached to the applicator and the afterloading system, provides a continuous closed passage that allows for moving either a radioactive source(s) and/or positioning markers from the shielded source storage compartment of the remote afterloading brachytherapy system into appropriate positions within a brachytherapy applicator that has been positioned at a location either on the surface of, or within, the patient.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
332474605
Device count
1
DM exempt
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810563023022Titanium Allen wrenchAL07342000AL073420002025-05-21
00816389027961Interstitial mini ovoid pair, with fixation for guide tubesGM11013420GM110134202025-05-21
00816389027978Interstitial ovoid pair for 20mm spread, with fixation for guide tubesGM11013430GM110134302025-05-21
00816389027985Interstitial ovoid pair for 25mm spread, with fixation for guide tubesGM11013440GM110134402025-05-21
00816389027992Interstitial ovoid pair for 30mm spread, with fixation for guide tubesGM11013450GM110134502025-05-21
00810563022933Ovoid \ cervical stop set screw (pack of 8)AL07335000AL073350002025-05-21
00810563022612Disassembly Pin, CT/ MRGM11012970GM110129702025-05-16
00816389029439CT/ MR Tandem and Ovoid Set (CTO)GM11012500GM110125002025-05-16
00816389029446Colpostat probe, left, CT/ MRGM11012660GM110126602025-05-16
00816389029453Colpostat probe, right, CT/ MRGM11012670GM110126702025-05-16
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRGM11012510GM110125102025-05-16
00816389029477Intrauterine tandem, 15 degrees, 4 cm, CT/ MRGM11012520GM110125202025-05-16
00816389029484Intrauterine tandem, 15 degrees, 6 cm, CT/ MRGM11012530GM110125302025-05-16
00816389029491Intrauterine tandem, 15 degrees, 8 cm, CT/ MRGM11012540GM110125402025-05-16
00816389029507Intrauterine tandem, 30 degrees, 2 cm, CT/ MRGM11012550GM110125502025-05-16
00816389029514Intrauterine tandem, 30 degrees, 4 cm, CT/ MRGM11012560GM110125602025-05-16
00816389029521Intrauterine tandem, 30 degrees, 6 cm, CT/ MRGM11012570GM110125702025-05-16
00816389029538Intrauterine tandem, 30 degrees, 8 cm, CT/ MRGM11012580GM110125802025-05-16
00816389029545Intrauterine tandem, 45 degrees, 2 cm, CT/ MRGM11012610GM110126102025-05-16
00816389029552Intrauterine tandem, 45 degrees, 4 cm, CT/ MRGM11012620GM110126202025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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