Pinnacle Chin Guard - Panoramic Chin Rest Cover - METREX RESEARCH, LLC

Duns Number:145963778

Device Description: Panoramic Chin Rest Cover

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More Product Details

Catalog Number

-

Brand Name

Pinnacle Chin Guard

Version/Model Number

7200C

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

MMP

Product Code Name

Cover, barrier, protective

Device Record Status

Public Device Record Key

082df492-d424-48bc-975e-86c9548754d8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"METREX RESEARCH, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 6