FDA.reportPublic FDA data

AOS Interstitial Templates, Needles, and Accesories

Primary DI
00850645007618
Brand
AOS Interstitial Templates, Needles, and Accesories
Company
ALPHA-OMEGA SERVICES, INC.
Model
NHD0001-005
Device description
Needle, Template Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 25 cm, 10ea
Published
2024-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233628000AOS Interstitial Templates, Needles, and AccessoriesAlpha-Omega Services, Inc.2024-07-10JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850645007618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850645007618008506450076188506450076180850645007618

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
060398989
Device count
1
Lot or batch
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850645007007AOS Marker SeedsSMG0242-0252024-07-15
00850645007601AOS Interstitial Templates, Needles, and AccesoriesNHD0001-0042024-07-18
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
00850645007229AOS Implant Tube, Tongue/Soft Tissue, Puthawala/SyedTIT0001-0052016-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.JAQ2026-07-23
00810563022551Needle collector pair for Titanium Fletcher-style applicatorVARIAN MEDICAL SYSTEMS, INC.JAQ2024-11-19
00850645007007AOS Marker SeedsALPHA-OMEGA SERVICES, INC.JAQ2024-07-15
00816389020245Crook Prostate Template for 2.0 mm needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-19
00810563021967Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563021974Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563021981Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563022001Mandrin for 200 mm lengthVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563022018Mandrin for 320 mm lengthVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00810563021998Mandrin for 113 mm lengthVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00816389022522Mandrin for 200mm length Needle for Plastic Interstitial NeedleVARIAN MEDICAL SYSTEMS, INC.JAQ2021-02-02
00863593000235HDR MRI Lumen MarkerC4 IMAGING, LLCJAQ2018-06-11
08717213043329X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043336X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043343X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043688X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043695X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043701X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043718X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043725X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043732X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043749X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043756X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043763X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213021662X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213028463X-ray CathetersNucletron B.V.JAQ2016-09-25
10816389027296Universal fixation button, radiopaque, pack of 100, non-sterileVARIAN MEDICAL SYSTEMS, INC.JAQ2016-09-23
00816389021747Central clamping mechanismVARIAN MEDICAL SYSTEMS, INC.JAQ2016-09-23
00816389021778Intrauterine probe with stop, 30 degrees angle, length 80mmVARIAN MEDICAL SYSTEMS, INC.JAQ2016-09-23