High Dose Rate Frame, SurePoint Stepper

GUDID 00852656007304

The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwich, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.

Best Nomos

Nonimplantable needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable
Primary Device ID00852656007304
NIH Device Record Keyd61ed011-f698-4d12-9cb9-9fe4f2de9bf6
Commercial Distribution StatusIn Commercial Distribution
Brand NameHigh Dose Rate Frame, SurePoint Stepper
Version Model Number6065
Company DUNS146920025
Company NameBest Nomos
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(412) 312-6700
Emailinfo@nomos.com
Phone(412) 312-6700
Emailinfo@nomos.com
Phone(412) 312-6700
Emailinfo@nomos.com
Phone(412) 312-6700
Emailinfo@nomos.com
Phone(412) 312-6700
Emailinfo@nomos.com
Phone(412) 312-6700
Emailinfo@nomos.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852656007304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IWJSystem, Applicator, Radionuclide, Manual

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00852656007304]

Moist Heat or Steam Sterilization


[00852656007304]

Moist Heat or Steam Sterilization


[00852656007304]

Moist Heat or Steam Sterilization


[00852656007304]

Moist Heat or Steam Sterilization


[00852656007304]

Moist Heat or Steam Sterilization


[00852656007304]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-23
Device Publish Date2016-10-31

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