DTE,WOODPECKER

GUDID 06944843605609

Ultrasonic dental scaling/debridement system

Guilin Woodpecker Medical Instrument Co., Ltd.

Ultrasonic dental scaling/debridement system
Primary Device ID06944843605609
NIH Device Record Keybc2e6fae-3b7f-4a36-b56e-2997ad96ce6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDTE,WOODPECKER
Version Model NumberSB6
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 Numberfalse
Manufacturing Datetrue
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
GS106944843605609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06944843605609]

Moist Heat or Steam Sterilization


[06944843605609]

Moist Heat or Steam Sterilization


[06944843605609]

Moist Heat or Steam Sterilization


[06944843605609]

Moist Heat or Steam Sterilization


[06944843605609]

Moist Heat or Steam Sterilization


[06944843605609]

Moist Heat or Steam Sterilization


[06944843605609]

Moist Heat or Steam Sterilization


[06944843605609]

Moist Heat or Steam Sterilization


[06944843605609]

Moist Heat or Steam Sterilization


[06944843605609]

Moist Heat or Steam Sterilization


[06944843605609]

Moist Heat or Steam Sterilization


[06944843605609]

Moist Heat or Steam Sterilization


[06944843605609]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-29
Device Publish Date2022-08-19

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