NA - Bite Wax Sticks soft yellow lemon 490g - Yeti Dentalprodukte GmbH

Duns Number:324001916

Device Description: Bite Wax Sticks soft yellow lemon 490g

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

612-0490

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)

-

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

EGD

Product Code Name

WAX, DENTAL, INTRAORAL

Device Record Status

Public Device Record Key

d88ac4ca-7c42-4802-acbc-3b25f3585738

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 19, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"YETI DENTALPRODUKTE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 21