FDA.reportPublic FDA data

Ovoid pair, ø 25 mm

Primary DI
10810563022978
Brand
Ovoid pair, ø 25 mm
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
GM11013620
Catalog number
GM11013620
Published
2025-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
K243939000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243939000Titanium Flexible Geometry FSD Applicator Set (GM11013400)Varian Medical Systems, Inc.2025-03-03JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810563022978PrimaryGS10
00810563022971Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081056302297810810563022978
00810563022971008105630229718105630229710810563022971

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
009120817
Device count
2
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810563022001Mandrin for 200 mm lengthGM11010450GM110104502024-02-16
10816389027296Universal fixation button, radiopaque, pack of 100, non-sterileGM11003800GM110038002016-09-23
00810563021967Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrinGM11014710GM110147102024-02-16
00810563021974Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrinGM11014720GM110147202024-02-16
00810563021981Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrinGM11014730GM110147302024-02-16
00810563022018Mandrin for 320 mm lengthGM11010470GM110104702024-02-16
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinGM11014700GM110147002024-02-16
00810563021998Mandrin for 113 mm lengthGM11010390GM110103902024-02-16
00816389022522Mandrin for 200mm length Needle for Plastic Interstitial NeedleGM11003270GM110032702021-02-02
00816389022188Flexible probe, 2.8 mm diameter x 320 mmGM11002280GM110022802016-09-22
00816389022195Mould probe, ø 1.8 diameter x 320 mm, with mandrinGM11002290GM110022902016-09-19
00816389022478Mandrin for 320mm lengthGM11003100GM110031002016-09-23
00816389022553Mandrin for 113mm length NeedleGM11003340GM110033402016-09-22
00816389022935Catheter flap 200 mm x 290 mm x 10 mm, 40 channelsGM11003910GM110039102016-09-23
00816389024243Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needlesGM11007560GM110075602016-09-22
00816389024250Plastic needle 2.0 mm diameter, 200 mm length with mandrin for 200 mm needlesGM11007570GM110075702016-09-18
00816389024267Plastic needle ø 2.0 mm diameter, 320 mm length with mandrin for 320 mm needlesGM11007580GM110075802016-09-19
00816389025615Plastic needle 2.0 mm diameter, 320 mm length, blunt tip w/ mandrinGM11010750GM110107502016-09-22
00854393006084Velocity4.3Velocity 4.32026-07-16
10816389027234Cleaning Cap, dark blue (pack of 25)GM11010770GM110107702016-09-22

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