MASSAD - MASSAD ANT U C1 / P3 - CMP INDUSTRIES LLC

Duns Number:002064319

Device Description: MASSAD ANT U C1 / P3

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More Product Details

Catalog Number

-

Brand Name

MASSAD

Version/Model Number

MAUC1P3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K101029

Product Code Details

Product Code

ELM

Product Code Name

Denture, Plastic, Teeth

Device Record Status

Public Device Record Key

3dc945db-486c-4e5d-9d70-80b86a48cfaa

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 20, 2018

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