FDA.report

WOODPECKER

Primary DI
06944843607252
Brand
WOODPECKER
Company
Guilin Woodpecker Medical Instrument Co., Ltd.
Model
YZ-1LY
Device description
Ultrasonic dental scaling/debridement system handpiece
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ELCScaler, Ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06944843607252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06944843607252069448436072526944843607252

GMDN Terms

TermDefinition
Ultrasonic dental scaling/debridement system handpieceA hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags

DUNS number
545272577
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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06944843619088EDEGENDOEDGEFLOW2025-03-11
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06944843617510DTEU6 LED2024-10-18
06944843655987DTEPT-B2024-10-18
06944843657721DTEi-Polish2024-10-18
06944843657745DTEK-Po2024-10-18
06944843658155woodpeckerV V Light2024-10-18
06944843658728DTELED.B2024-10-18
06944843659916woodpeckerUDS-T LED2024-10-18
06944843660165DTED8 LED2024-10-18
06944843662596woodpeckerProphy-Mini2024-10-18
06944843600987DTEImplant-X2024-10-17
06944843600994woodpeckerImplanter2024-10-17

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00810126506269Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
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