FDA.reportPublic FDA data

Reusable Frame, Bard SurePoint Stepper

Primary DI
00852656007182
Brand
Reusable Frame, Bard SurePoint Stepper
Company
Best Nomos
Model
6051
Device description
The Bard SurePoint Stepper Reusable Frame, when used in conjunction with a disposable template, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
Published
2016-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWJSystem, Applicator, Radionuclide, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWJSystem, Applicator, Radionuclide, ManualRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973786000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973786000NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDENw Radiation Therapy Products1998-01-02IWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852656007182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852656007182008526560071828526560071820852656007182

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, reusableA non-powered device designed to lead a needle into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(412) 312-6700info@nomos.com

Regulatory Flags#

DUNS number
146920025
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852656007229Disposable Template, 18 Gauge, Non-Siemens, 5 Pack60462016-10-31
00852656007236Disposable Template, 18 Gauge, Siemens, 5 Pack60472016-10-31
00852656007243Disposable Template, 17 Gauge, Non-Siemens, 5 Pack60482016-10-31
00852656007250Disposable Template, 17 Gauge, Siemens, 5 Pack60492016-10-31
00852656007335Disposable Template, 18 Gauge, Non-Siemens, Single61042016-10-31
00852656007342Disposable Template, 18 Gauge, Siemens, Single61052016-10-31
00852656007359Disposable Template, 17 Gauge, Non-Siemens, Single61062016-10-31
00852656007366Disposable Template, 17 Gauge, Siemens, Single61072016-10-31
00852656007519Cradle, SonoScape2107812022-11-17
00852656007175Reusable Frame, Best Precision Stepper60502016-10-31
00852656007199Reusable Frame, Civco/BW Stepper (Non-Siemens Grid)60522016-10-31
00852656007205Reusable Frame, Civco/BW Stepper (Siemens Grid)60532016-10-31
00852656007212Reusable Frame, CMS AccuSeed60622016-10-31
00852656007267High Dose Rate Frame, Best Precision Stepper (Siemens Grid)60122016-10-31
00852656007274High Dose Rate Frame, Best Precision Stepper (BK Grid)60362016-10-31
00852656007281High Dose Rate Frame, Civco/BW Stepper60632016-10-31
00852656007298High Dose Rate Frame, Tayman Stepper60642016-10-31
00852656007304High Dose Rate Frame, SurePoint Stepper60652016-10-31
00852656007311High Dose Rate Sandwich, 15 Gauge60132016-10-31
00852656007328High Dose Rate Sandwich, 17 Gauge60332016-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B16556330328053126035Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B1655635032805302533Implant NeedleLiberty Medical , Inc.IWJ2026-06-01
B1655662032805302615Intrauterine TandemLiberty Medical , Inc.IWJ2026-06-01
B16558010327123126103Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B16558010328010026067Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B165580203270931260031Large Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B16558110328022826066Medium Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-06-01
B16559050328053126091ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559060328053026074ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559090328053026060ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559100328053026079ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16570160328053126101Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B16570170328053126102Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B16570940328053126107AdapterLiberty Medical , Inc.IWJ2026-06-01
00841365121579Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-29
00841365121562Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-21
00841365121555Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-15
B201CGSG140Clear Guide SteriGRIDCLEAR GUIDE MEDICAL, INC.IWJ2026-05-11
00841365121548Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-06
B165565003280430252241Small Prostate TemplateLiberty Medical , Inc.IWJ2026-05-01
B16556510328043026077Medium Prostate TemplateLiberty Medical , Inc.IWJ2026-05-01
B165576403280430260101Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16557640328043026081Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16557650328040025244Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16559060328043026048ButtonsLiberty Medical , Inc.IWJ2026-05-01
B16559070328043025007ButtonsLiberty Medical , Inc.IWJ2026-05-01
B16570160328043026056Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16570170328043026057Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
00841365121524Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-04-29
00841365121517Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-04-16