DTE

GUDID 06944843660165

Ultrasonic Scaler

Guilin Woodpecker Medical Instrument Co., Ltd.

Ultrasonic dental scaling/debridement system
Primary Device ID06944843660165
NIH Device Record Key99459b59-dc3e-4cf5-9396-740292ffee86
Commercial Distribution StatusIn Commercial Distribution
Brand NameDTE
Version Model NumberD8 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 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
GS106944843660165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06944843660165]

Moist Heat or Steam Sterilization

[06944843660165]

Moist Heat or Steam Sterilization

[06944843660165]

Moist Heat or Steam Sterilization

[06944843660165]

Moist Heat or Steam Sterilization

[06944843660165]

Moist Heat or Steam Sterilization

[06944843660165]

Moist Heat or Steam Sterilization

[06944843660165]

Moist Heat or Steam Sterilization

[06944843660165]

Moist Heat or Steam Sterilization

[06944843660165]

Moist Heat or Steam Sterilization

[06944843660165]

Moist Heat or Steam Sterilization

[06944843660165]

Moist Heat or Steam Sterilization

[06944843660165]

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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06944843602424Curing Light
06944843602332Dental Curing Light
06944843602271Dental Curing Light
06944843602264Curing Light
06944843602257Dental Curing Light
06944843602240Curing Light
06944843602233Dental Curing Light
06944843602226Curing Light
06944843602219Dental Curing Light
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06944843601120Dental Ultrasonic Scaler
06944843601113Ultrasonic Scalers
06944843601106Dental Ultrasonic Scaler
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06944843601083Dental Ultrasonic Scaler
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06944843601021Dental Ultrasonic Scaler
06944843601014Ultrasonic Scalers
06944843600864Tips of Ultrasonic Scalers
06944843600857Tips of Ultrasonic Scalers
06944843600840Tips of Ultrasonic Scalers
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