High Dose Rate Frame, Best Precision Stepper (Siemens Grid) - The High Dose Rate Frame, when used in - Best Nomos

Duns Number:146920025

Device Description: The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwich, is used 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.

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More Product Details

Catalog Number

-

Brand Name

High Dose Rate Frame, Best Precision Stepper (Siemens Grid)

Version/Model Number

6012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K973786

Product Code Details

Product Code

IWJ

Product Code Name

System, Applicator, Radionuclide, Manual

Device Record Status

Public Device Record Key

f3c9f4ec-60ae-4722-a2cb-bec96c0a6e66

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

October 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEST NOMOS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 15