WOODPECKER - Dental power tool system handpiece, - Guilin Woodpecker Medical Instrument Co., Ltd.

Duns Number:545272577

Device Description: Dental power tool system handpiece, remotely-driven

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More Product Details

Catalog Number

-

Brand Name

WOODPECKER

Version/Model Number

E-COM+

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

K203320

Product Code Details

Product Code

EKX

Product Code Name

Handpiece, Direct Drive, Ac-Powered

Device Record Status

Public Device Record Key

4947f793-05e0-4fed-86ce-cd0cf6bf9ec6

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 20, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 61
2 A medical device with a moderate to high risk that requires special controls. 779
U Unclassified 14