CT/MR M.A.C. Interstitial GYN Template,1.65mmElekt - MICK RADIO NUCLEAR INSTRUMENT, INC

Duns Number:073260622

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More Product Details

Catalog Number

1505-1.65

Brand Name

CT/MR M.A.C. Interstitial GYN Template,1.65mmElekt

Version/Model Number

1505-1.65

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

JAQ

Product Code Name

System, Applicator, Radionuclide, Remote-Controlled

Device Record Status

Public Device Record Key

485187ed-200f-48c5-8ff6-7fe304a21f11

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICK RADIO NUCLEAR INSTRUMENT, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 659