FDA.reportPublic FDA data

Kobold® Prostate HDR Template - 16 ga/5 Fr

Primary DI
00815568021264
Brand
Kobold® Prostate HDR Template - 16 ga/5 Fr
Company
KOBOLD, LLC
Model
802-000
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
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
K170203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170203000System, Applicator, Radionuclide, Remote ControlledKobold, LLC2017-06-01JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815568021264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815568021264008155680212648155680212640815568021264

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA 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 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
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
00815568020168Kobold® Prone Belly Board315-0002016-09-23

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
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
08717213008274MicroSelectron DigitalNucletron B.V.JAQ2018-06-14
08717213014022Standard CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014039Standard CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014145Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014152Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014169Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014206Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09