Nobilium - CRCB TECHNOFLX SPARTALLOY - CMP INDUSTRIES LLC

Duns Number:002064319

Device Description: CRCB TECHNOFLX SPARTALLOY

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More Product Details

Catalog Number

-

Brand Name

Nobilium

Version/Model Number

0020GB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 08, 2016

Issuing Agency

In HIBCC

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

Yes

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

EJH

Product Code Name

Alloy, Metal, Base

Device Record Status

Public Device Record Key

58c584db-8762-4d9f-95da-948529563300

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CMP INDUSTRIES LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 92
2 A medical device with a moderate to high risk that requires special controls. 2024