AccessGUDID - DEVICE: Diode Laser Tips (00647529004647)

GUDID

Device Identifier (DI) Information

Brand Name: Diode Laser Tips
Version or Model: Epic Q, surgical assortment kit, 30PK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6400258
Company Name: Biolase, Inc.

Primary DI Number: 00647529004647
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 152165700 *Terms of Use

Device Description: An assortment kit composed of thirty single-use fiberoptic laser tip intended for use with Biolase diode laser systems.

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:	Yes
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 [?]
K121286	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 4 Millimeter
Outer Diameter: 400 Micrometer
Outer Diameter: 200 Micrometer
Outer Diameter: 300 Micrometer

Device Record Status

Public Device Record Key: 8c0806c3-226c-44cb-aeeb-bcfe20d2144c
Public Version Date: May 07, 2024
Public Version Number: 1
DI Record Publish Date: April 29, 2024