FDA.reportPublic FDA data

Kobold® Tandem and 45 Deg Ring Applicator Set (E)

Primary DI
00815568020052
Brand
Kobold® Tandem and 45 Deg Ring Applicator Set (E)
Company
KOBOLD, LLC
Model
707-003
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
K142330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142330000Kobold Ring and Tandem Applicator SetKobold, LLC2015-04-09JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815568020052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815568020052008155680200528155680200520815568020052

GMDN Terms#

Term, Definition table
TermDefinition
Cervical/intrauterine brachytherapy system applicator, remote-afterloadingA remote afterloading brachytherapy applicator specifically designed for use in cervical or intrauterine radiation therapy treatments. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the cervical or intrauterine anatomy. This GMDN code includes a wide variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle45degree

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
014292258
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815568021226Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr812-0002019-11-20
00815568021233Kobold® Prostate HDR Stepper Template - 16 ga/5 Fr811-0002019-11-20
00815568021240Kobold® Prostate HDR Template - 18 ga804-0002019-11-20
00815568021257Kobold® Prostate HDR Template - 17 ga/4 Fr803-0002019-11-20
00815568021264Kobold® Prostate HDR Template - 16 ga/5 Fr802-0002019-11-20
00815568020892Kobold® Prostate HDR Stepper Template - 6 Fr813-0002019-12-09
00815568020090Kobold® Prostate HDR Template - 16 ga/5 Fr802-0002017-07-18
00815568020106Kobold® Prostate HDR Template - 17 ga/4 Fr803-0002017-07-18
00815568020113Kobold® Prostate HDR Template - 18 ga804-0002017-07-18
00815568020137Kobold® Prostate HDR Stepper Template - 16 ga/5 Fr811-0002017-07-18
00815568020144Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr812-0002017-07-19
00815568020922Kobold® Henschke-model Tandem and Ovoid Applicator Set (E)704-0002019-03-25
00815568020977Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E)708-0012019-03-25
00815568020984Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E)708-0022019-03-25
00815568020991Kobold® Vaginal Cylinder Applicator Set (E)715-0002019-03-25
00815568020007Kobold® Henschke-model Tandem and Ovoid Applicator Set (E)704-0002016-09-23
00815568020014Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E)708-0012016-09-23
00815568020021Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E)708-0022016-09-23
00815568020076Kobold® Vaginal Cylinder Applicator Set (E)715-0002016-09-23
00815568020151Kobold® Prone Breast Board325-0002016-09-23

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
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
08717213009585Miami 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