FDA.report

BLU

Primary DI
00887919929048
Brand
BLU
Company
Peter Brasseler Holdings, LLC
Model
5029470U0
Device description
BLU LASER BATTERY LITHION
Published
2022-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887919929048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919929048008879199290488879199290480887919929048

GMDN Terms

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

Regulatory Flags

DUNS number
082080136
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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