DTE

GUDID 06944843603209

Dental power tool system handpiece, remotely-driven

Guilin Woodpecker Medical Instrument Co., Ltd.

Dental power tool system handpiece, remotely-driven
Primary Device ID06944843603209
NIH Device Record Keyf5a1cbe0-59e6-4abe-a8fe-e3e1fdcde7e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDTE
Version Model NumberE-COM+
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944843603209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06944843603209]

Moist Heat or Steam Sterilization

[06944843603209]

Moist Heat or Steam Sterilization

[06944843603209]

Moist Heat or Steam Sterilization

[06944843603209]

Moist Heat or Steam Sterilization

[06944843603209]

Moist Heat or Steam Sterilization

[06944843603209]

Moist Heat or Steam Sterilization

[06944843603209]

Moist Heat or Steam Sterilization

[06944843603209]

Moist Heat or Steam Sterilization

[06944843603209]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-30
Device Publish Date2021-08-20

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