NA - A dental instrument shaped as a kind of lever - YDM CORPORATION

Duns Number:716059766

Device Description: A dental instrument shaped as a kind of lever designed for use during extraction of teeth A dental instrument shaped as a kind of lever designed for use during extraction of teeth or roots.

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More Product Details

Catalog Number

16055

Brand Name

NA

Version/Model Number

16055

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

EMJ

Product Code Name

Elevator, Surgical, Dental

Device Record Status

Public Device Record Key

3dbe4bb6-8582-47e9-9c0b-de97f72ce7e2

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"YDM CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 163