FDA.reportPublic FDA data

Pioneer Elite Ergonomic Handpiece Sleeve

Primary DI
00872320000868
Brand
Pioneer Elite Ergonomic Handpiece Sleeve
Company
CAO GROUP, INC.
Model
04073
Device description
Removable surgical handpiece sleeve for the Pioneer Elite Diode Laser.
Published
2017-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00872320001605PackageGS11In Commercial Distribution
00872320004903PackageGS11In Commercial Distribution
00872320000868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00872320001605008723200016058723200016050872320001605
00872320004903008723200049038723200049030872320004903
00872320000868008723200008688723200008680872320000868

GMDN Terms#

Term, Definition table
TermDefinition
Dental diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
866-999-2635support@amdlasers.com
801-256-9282info@pioneerlasers.com

Regulatory Flags#

DUNS number
102422578
Device count
1
Lot or batch
true
Sterilization required before use
true

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