FDA.report

WOODPECKER

Primary DI
06944843601656
Brand
WOODPECKER
Company
Guilin Woodpecker Medical Instrument Co., Ltd.
Model
U600
Device description
Dental Ultrasonic Scaler
Published
2016-09-10
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
06944843601656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06944843601656069448436016566944843601656

GMDN Terms

TermDefinition
Ultrasonic dental scaling/debridement systemAn assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).

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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