FDA.reportPublic FDA data

400um Strippable Fiber - FC Connection

Primary DI
00851759007136
Brand
400um Strippable Fiber - FC Connection
Company
AMD Lasers
Model
SF400-FC
Catalog number
SF400-FC
Device description
400um strippable fiber for use with the Picasso or Picasso Lite soft-tissue dental lasers. The strippable fiber has an orange strain relief and an FC connector.
Published
2016-09-20
Public version status
Update
Distribution status
Not 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
00851759007136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851759007136008517590071368517590071360851759007136

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity25 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius32 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity25 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-999-2635support@amdlasers.com

Regulatory Flags#

DUNS number
080354039
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851759007006Picasso Plus Dental Diode LaserP810PPLUS2016-09-20
00851759007013Picasso Lite Plus Dental Diode LaserPL810PLPLUS2016-09-20
00851759007020AMD LASERS Bendable Disposable Tips (Assortment of 25)TIP25TIP252016-09-20
00851759007037Bendable Disposable Tips (Box of 25) 400um, 60 degree, 5mmTIP4006005TIP40060052016-09-20
00851759007044Bendable Disposable Tips (Box of 25) 400um, 60 degree, 10mmTIP4006010TIP40060102016-09-20
00851759007051Bendable Disposable Tips (Box of 25) 300um, 60 degree, 5mmTIP3006005TIP30060052016-09-20
00851759007068Bendable Disposable Tips (Box of 25) 300um, 60 degree, 10mmTIP3006010TIP30060102016-09-20
00851759007075Bendable Disposable Tips (Box of 20) 200um, 60 degree, 20mmTIP2006020TIP20060202016-09-20
00851759007082Multi-Tip Handpiece - Picasso Plus (Orange)MTHP-PPLUSMTHP-PPLUS2016-09-20
00851759007099Multi-Tip Handpiece - Picasso Lite Plus (Black)MTHP-PLPLUSMTHP-PLPLUS2016-09-20
00851759007105Quadra TipQTQT2016-09-20
00851759007112Multi-Tip Handpiece - Picasso (Orange)STF400STF4002016-09-20
00851759007129Multi-Tip Handpiece - Picasso Lite (Black)STF200STF2002016-09-20
00851759007143400um Strippable Fiber - Plus SeriesSF400-PLUSSF400-PLUS2016-09-20
00851759007150400um Strippable Fiber - ST ConnectionSF400-STSF400-ST2016-09-20
00851759007167Laser Safety Goggles (Sport Frame)EYEEYE2016-09-20
00851759007174Laser Safety Goggles (fit-over frame)EYEFEYEF2016-09-20

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