FDA.reportPublic FDA data

AOS Implant Tube, Tongue/Soft Tissue, Puthawala/Syed

Primary DI
00850645007229
Brand
AOS Implant Tube, Tongue/Soft Tissue, Puthawala/Syed
Company
ALPHA-OMEGA SERVICES, INC.
Model
TIT0001-005
Device description
Implant Tube, Tongue/Soft Tissue, Puthawala/Syed, 28 cm Leader, 85 cm Body, 15 cm Draw-Down, Cable Insert, with Green Nylon Retaining Buttons, 20 ea
Published
2016-10-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JAQSystem, Applicator, Radionuclide, Remote-Controlled

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850645007229PrimaryGS10
00850645007755Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850645007229008506450072298506450072290850645007229
00850645007755008506450077558506450077550850645007755

GMDN Terms#

Term, Definition table
TermDefinition
Tongue brachytherapy system applicator, remote-afterloadingA remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the tongue or oral cavity. It is typically designed for temporary implantation within the tongue and/or the tissue surrounding the tongue and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
060398989
Device count
20
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850645007601AOS Interstitial Templates, Needles, and AccesoriesNHD0001-0042024-07-18
00850645007618AOS Interstitial Templates, Needles, and AccesoriesNHD0001-0052024-07-18
00850645007625AOS Interstitial Templates, Needles, and AccesoriesTGD0003-0152024-07-18
00850645007632AOS Interstitial Templates, Needles, and AccesoriesTGD0003-0172024-07-18
00850645007649AOS Interstitial Templates, Needles, and AccesoriesTPD0001-0152024-07-18
00850645007656AOS Interstitial Templates, Needles, and AccesoriesTPD0001-0172024-07-18
00850645007076AOS Implant Needle, Series-17, 15 cm, 45°NID0001-0092016-10-05
00850645007083AOS implant Needle, Series-17, 20 cm, 14°NID0001-0102016-10-05
00850645007106AOS Implant Needle, Series-17, 20 cm, 45°NID0001-0122016-10-05
00850645007120AOS Implant Tube, Breast/Head/Neck, Puthawala/SyedTIB0001-0022016-10-05
00850645007137AOS Implant Tube, Breast/Head/Neck, Puthawala/SyedTIB0001-0032016-10-05
00850645007144AOS Implant Tube, IntralumenalTII0002-0012016-10-05
00850645007151AOS Implant Tube, IntralumenalTII0002-0022016-10-05
00850645007168AOS Implant Tube, IntralumenalTII0004-0012016-10-05
00850645007175AOS Implant Tube, IntralumenalTII0005-0012016-10-05
00850645007182AOS Implant Tube, IntralumenalTII0005-0062016-10-05
00850645007199AOS Implant Tube, IntralumenalTII0005-0112016-10-05
00850645007205AOS Implant TubeTIS0002-0022016-10-05
00850645007212AOS Implant Tube, Tongue/Soft Tissue, Puthawala/SyedTIT0001-0042016-10-05
00850645007236AOS Collar and Large O-RingCTG1517-0012016-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816389028081MAASTRO Rectal Applicator Set, ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-06-02
00816389027992Interstitial ovoid pair for 30mm spread, with fixation for guide tubesVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-21
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029538Intrauterine tandem, 30 degrees, 8 cm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029637Ovoid, 40 mm, pair, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029699Assembly module, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029712Retractor, 30 mm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029743Retraction Nut CT/MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00810563022551Needle collector pair for Titanium Fletcher-style applicatorVARIAN MEDICAL SYSTEMS, INC.JAQ2024-11-19
00816389020245Crook Prostate Template for 2.0 mm needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-19
00816389020276Crook Prostate Template for 17 gauge (1.47 mm) needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-19
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00816389029286Stainless steel needle 320mm, 18 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-05-05
00816389029217Stainless steel needle 113mm, 17 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389029224Stainless steel needle 200mm, 17 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389029255Stainless steel needle 113mm, 18 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389028869VariSource VS2000 HDR Ir 192 Brachytherapy Sealed SourceVARIAN MEDICAL SYSTEMS, INC.JAQ2022-01-09
00816389027756Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 50mmVARIAN MEDICAL SYSTEMS, INC.JAQ2019-11-06
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
08717213007772Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007796Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007826Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009318Esophageal ApplicatorNucletron B.V.JAQ2018-06-27
08717213007765Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213009042Esophageal ApplicatorNucletron B.V.JAQ2018-06-20