Home GUDID 00815568021226 Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr
Primary DI 00815568021226
Brand Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr
Company KOBOLD, LLC
Model 812-000
Device description Labelled with CE
Published 2019-11-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Single use true Product Codes# Code, Name table Code Name JAQ System, Applicator, Radionuclide, Remote-Controlled
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815568021226 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00815568021226 00815568021226 815568021226 0815568021226
GMDN Terms# Term, Definition table Term Definition Nonimplantable needle guide, single-use A rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.
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 DI Brand Model Catalog Published 00815568021233 Kobold® Prostate HDR Stepper Template - 16 ga/5 Fr 811-000 2019-11-20 00815568021240 Kobold® Prostate HDR Template - 18 ga 804-000 2019-11-20 00815568021257 Kobold® Prostate HDR Template - 17 ga/4 Fr 803-000 2019-11-20 00815568021264 Kobold® Prostate HDR Template - 16 ga/5 Fr 802-000 2019-11-20 00815568020892 Kobold® Prostate HDR Stepper Template - 6 Fr 813-000 2019-12-09 00815568020090 Kobold® Prostate HDR Template - 16 ga/5 Fr 802-000 2017-07-18 00815568020106 Kobold® Prostate HDR Template - 17 ga/4 Fr 803-000 2017-07-18 00815568020113 Kobold® Prostate HDR Template - 18 ga 804-000 2017-07-18 00815568020137 Kobold® Prostate HDR Stepper Template - 16 ga/5 Fr 811-000 2017-07-18 00815568020144 Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr 812-000 2017-07-19 00815568020922 Kobold® Henschke-model Tandem and Ovoid Applicator Set (E) 704-000 2019-03-25 00815568020977 Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E) 708-001 2019-03-25 00815568020984 Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E) 708-002 2019-03-25 00815568020991 Kobold® Vaginal Cylinder Applicator Set (E) 715-000 2019-03-25 00815568020007 Kobold® Henschke-model Tandem and Ovoid Applicator Set (E) 704-000 2016-09-23 00815568020014 Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E) 708-001 2016-09-23 00815568020021 Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E) 708-002 2016-09-23 00815568020076 Kobold® Vaginal Cylinder Applicator Set (E) 715-000 2016-09-23 00815568020151 Kobold® Prone Breast Board 325-000 2016-09-23 00815568020168 Kobold® Prone Belly Board 315-000 2016-09-23
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00841436125451 Classic Stepper CIVCO MEDICAL INSTRUMENTS CO., INC. JAQ 2026-07-23 00810563022551 Needle collector pair for Titanium Fletcher-style applicator VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-11-19 00850645007007 AOS Marker Seeds ALPHA-OMEGA SERVICES, INC. JAQ 2024-07-15 00816389020245 Crook Prostate Template for 2.0 mm needles VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-19 00810563021967 Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrin VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00810563021974 Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrin VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00810563021981 Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrin VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00810563022001 Mandrin for 200 mm length VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00810563022018 Mandrin for 320 mm length VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00810563022025 Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00810563021998 Mandrin for 113 mm length VARIAN MEDICAL SYSTEMS, INC. JAQ 2024-02-16 00816389022522 Mandrin for 200mm length Needle for Plastic Interstitial Needle VARIAN MEDICAL SYSTEMS, INC. JAQ 2021-02-02 00863593000235 HDR MRI Lumen Marker C4 IMAGING, LLC JAQ 2018-06-11 08717213043329 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043336 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043343 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043688 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043695 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043701 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043718 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043725 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043732 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043749 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043756 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213043763 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213021662 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 08717213028463 X-ray Catheters Nucletron B.V. JAQ 2016-09-25 10816389027296 Universal fixation button, radiopaque, pack of 100, non-sterile VARIAN MEDICAL SYSTEMS, INC. JAQ 2016-09-23 00816389021747 Central clamping mechanism VARIAN MEDICAL SYSTEMS, INC. JAQ 2016-09-23 00816389021778 Intrauterine probe with stop, 30 degrees angle, length 80mm VARIAN MEDICAL SYSTEMS, INC. JAQ 2016-09-23