DTE

GUDID 06944843657721

Cordless Prophy System

Guilin Woodpecker Medical Instrument Co., Ltd.

Dental surgical power tool motorized handpiece/set, electric
Primary Device ID06944843657721
NIH Device Record Key58cfb47a-1544-4e52-ad8e-9b9ba08df374
Commercial Distribution StatusIn Commercial Distribution
Brand NameDTE
Version Model Numberi-Polish
Company DUNS545272577
Company NameGuilin Woodpecker Medical Instrument Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944843657721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06944843657721]

Moist Heat or Steam Sterilization

[06944843657721]

Moist Heat or Steam Sterilization

[06944843657721]

Moist Heat or Steam Sterilization

[06944843657721]

Moist Heat or Steam Sterilization

[06944843657721]

Moist Heat or Steam Sterilization

[06944843657721]

Moist Heat or Steam Sterilization

[06944843657721]

Moist Heat or Steam Sterilization

[06944843657721]

Moist Heat or Steam Sterilization

[06944843657721]

Moist Heat or Steam Sterilization

[06944843657721]

Moist Heat or Steam Sterilization

[06944843657721]

Moist Heat or Steam Sterilization

[06944843657721]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-28
Device Publish Date2024-10-18

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