DTE

GUDID 06944843604558

Dental power tool system handpiece, remotely-driven

Guilin Woodpecker Medical Instrument Co., Ltd.

Dental power tool system handpiece, remotely-driven
Primary Device ID06944843604558
NIH Device Record Keye587bb93-8095-4094-b216-e5d82d4a1418
Commercial Distribution StatusIn Commercial Distribution
Brand NameDTE
Version Model NumberEndo Gold+
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
GS106944843604558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKXHandpiece, Direct Drive, Ac-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06944843604558]

Moist Heat or Steam Sterilization

[06944843604558]

Moist Heat or Steam Sterilization

[06944843604558]

Moist Heat or Steam Sterilization

[06944843604558]

Moist Heat or Steam Sterilization

[06944843604558]

Moist Heat or Steam Sterilization

[06944843604558]

Moist Heat or Steam Sterilization

[06944843604558]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-31
Device Publish Date2021-08-23

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