Myerson db plus - Upper Bicuspid shade B2, mould X36 - The Myerson Company Limited

Duns Number:857278431

Device Description: Upper Bicuspid shade B2, mould X36

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More Product Details

Catalog Number

-

Brand Name

Myerson db plus

Version/Model Number

T3XB2U0X36

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

K924526

Product Code Details

Product Code

ELM

Product Code Name

Denture, Plastic, Teeth

Device Record Status

Public Device Record Key

d22ff420-4bf0-4f70-917c-bdbc89165473

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THE MYERSON COMPANY LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 134
2 A medical device with a moderate to high risk that requires special controls. 7702