DBA

GUDID 06944843605166

Ultrasonic dental scaling/debridement system

Guilin Woodpecker Medical Instrument Co., Ltd.

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Primary Device ID06944843605166
NIH Device Record Keyf1c574c4-275b-4645-8764-56d887d28bde
Commercial Distribution StatusIn Commercial Distribution
Brand NameDBA
Version Model NumberD3 LED
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
GS106944843605166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


[06944843605166]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-02
Device Publish Date2021-08-25

On-Brand Devices [DBA]

06944843602417Curing Light
06944843601762Ultrasonic Scalers
06944843601755Ultrasonic Scalers
06944843605166Ultrasonic dental scaling/debridement system
06944843611488Dental delivery system instrument unit, electric
06944843611310Gutta-percha injector
06944843611303Gutta-percha injector
06944843611242Dental digital imaging sensor, intraoral
06944843611099Dental digital imaging sensor, intraoral

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