Blue EF Series,Retainer - Modern Dental Laboratory (DG) Co., Ltd.

Duns Number:551746187

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More Product Details

Catalog Number

-

Brand Name

Blue EF Series,Retainer

Version/Model Number

174

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)

-

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

DYT

Product Code Name

Maintainer, Space Preformed, Orthodontic

Device Record Status

Public Device Record Key

af0a0fe3-bd7b-46e9-ae8b-de1b73ea73bd

Public Version Date

September 05, 2022

Public Version Number

1

DI Record Publish Date

August 26, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MODERN DENTAL LABORATORY (DG) CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 24