AccessGUDID - DEVICE: 400um Strippable Fiber - ST Connection (00851759007150)

GUDID

Device Identifier (DI) Information

Brand Name: 400um Strippable Fiber - ST Connection
Version or Model: SF400-ST
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SF400-ST
Company Name: AMD Lasers

Primary DI Number: 00851759007150
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 080354039 *Terms of Use

Device Description: 400um strippable fiber for use with the Picasso soft-tissue dental lasers. The strippable fiber has a black strain relief and an ST connection for legacy Picasso units.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60340	Dental diode laser system	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 50 Degrees Celsius
Storage Environment Humidity: between 25 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 15 and 32 Degrees Celsius
Handling Environment Humidity: between 25 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ddfff31c-6508-40ff-84fc-6e00fdec440f
Public Version Date: November 03, 2020
Public Version Number: 4
DI Record Publish Date: September 20, 2016