Crook Prostate Template for 17 gauge (1.47 mm) needles

Primary DI
00816389020276
Brand
Crook Prostate Template for 17 gauge (1.47 mm) needles
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
GM11012260
Catalog number
GM11012260
Device description
Siemens labelling, including locking collets (pack of 25) and needle collet wrench
Published
2024-02-19
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
K232949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232949000Kelowna GYN and Crook Prostate TemplatesVarian Medical Systems, Inc.2024-02-01JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816389020276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816389020276008163890202768163890202760816389020276

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose brachytherapy system applicator, remote-afterloadingA general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
009120817
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinGM11014700GM110147002024-02-16
00810563022322Temperature Sensor Probe, 18G x 20cmABL-18TP202024-08-09
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRGM11012510GM110125102025-05-16
00816389029637Ovoid, 40 mm, pair, CT/ MRGM11012750GM110127502025-05-16
00816389029712Retractor, 30 mm, CT/ MRGM11012930GM110129302025-05-16
008105630209538mm CryoprobeDP35-0215-101CRYO-48-F2022-02-18
00810563020984MicroThermX Microwave Ablation System20-17222-001MTX-1802022-02-18
00810563020991MicroThermX Microwave Ablation System20-17222-101MTX180-T22022-02-18
008163890289062.4mm V-Probe™ CryoprobeDP35-0900-101CVA24002022-02-18
008163890289202.4mm V-Probe™ Cryoprobe Right AngleDP35-0902-108CVA2400RA2022-02-18
00816389028869VariSource VS2000 HDR Ir 192 Brachytherapy Sealed SourceAL09400000AL094000002022-01-09
00856104006000Varian Treatment13.02016-09-16
00856545006027VariSource iX1.2AL19004-0002016-09-16
00856545006034VariSource iX(t)1.2AL19004-0012016-09-16
00816389020986TANDEM ROTATE & SLIDE BLOCK (CT/MR FSD)AL10715008AL107150082016-09-19
00816389021686Intrauterine probe with stopper, angle 30 degrees, length 50 mmGM11000790GM110007902016-09-23
00816389021785Mini-colpostats, pairGM11000900GM110009002016-09-19
00816389022164Applicator probe 6/3 mm diameter, curved 15 degrees, length 320 mmGM110022302016-09-22
00816389022386Implant needle, 120 mm, 1.7 mm diameter, curvedGM11002930GM110029302016-09-23
00816389022553Mandrin for 113mm length NeedleGM11003340GM110033402016-09-22

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
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029637Ovoid, 40 mm, pair, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029712Retractor, 30 mm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
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
00816389028869VariSource VS2000 HDR Ir 192 Brachytherapy Sealed SourceVARIAN MEDICAL SYSTEMS, INC.JAQ2022-01-09
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