Nu Alloy dp40 Caps. Jar X 500 - 1 Spill - Nu Alloy dp40 Caps. Jar X 500 - 1 Spill - PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A

Duns Number:880141023

Device Description: Nu Alloy dp40 Caps. Jar X 500 - 1 Spill

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More Product Details

Catalog Number

0013416

Brand Name

Nu Alloy dp40 Caps. Jar X 500 - 1 Spill

Version/Model Number

0013416

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140125

Product Code Details

Product Code

EJJ

Product Code Name

Alloy, Amalgam

Device Record Status

Public Device Record Key

9c5b3afc-cf2e-46aa-9c8d-85b344b6512c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 94