FDA.report

WOODPECKER

Primary DI
06944843602011
Brand
WOODPECKER
Company
Guilin Woodpecker Medical Instrument Co., Ltd.
Model
LED.B
Device description
Dental Curing Light
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
EBZActivator, Ultraviolet, For Polymerization

Product Code Classifications

CodeDeviceSpecialtyClass
EBZActivator, Ultraviolet, For PolymerizationDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06944843602011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06944843602011069448436020116944843602011

GMDN Terms

TermDefinition
Dental/surgical polymerization lampA mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.

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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J014660164550Starlight proKulzer GmbHEBZ2026-01-28
J014660573650Starlight proKulzer GmbHEBZ2026-01-28
J014660968300Starlight proKulzer GmbHEBZ2026-01-28
J014660969290Starlight proKulzer GmbHEBZ2026-01-28
J014660971690Starlight proKulzer GmbHEBZ2026-01-28
J014660971700Starlight proKulzer GmbHEBZ2026-01-28
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