Dolder® System - Dolder® SystemParallelometer insert micro(Bar - Cendres+Métaux SA

Duns Number:487506230

Device Description: Dolder® SystemParallelometer insert micro(Bar attachment)

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More Product Details

Catalog Number

070143

Brand Name

Dolder® System

Version/Model Number

070143

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

-

Product Code Details

Product Code

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

0d3c78ad-9cb6-4ebc-8dd7-d2a776e02e39

Public Version Date

August 11, 2020

Public Version Number

1

DI Record Publish Date

August 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CENDRES+MÉTAUX SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 208
2 A medical device with a moderate to high risk that requires special controls. 535