AccessGUDID - DEVICE: Diode Laser Tips (00647529004005)

GUDID

Device Identifier (DI) Information

Brand Name: Diode Laser Tips
Version or Model: Diode Laser Tips - Starter Kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6400165
Company Name: Biolase, Inc.

Primary DI Number: 00647529004005
Issuing Agency: GS1
Commercial Distribution End Date: December 20, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 152165700 *Terms of Use

Device Description: An assortment kit containing a combination of uninitiated and pre-initiated laser tips intended for use with Biolase diode lasers only. The tips have the same core diameter of 400 microns and different lenghts. The tips are non-sterile for single use only and require sterilization prior to use.

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:	Yes
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?
63476	General/multiple surgical laser system beam guide, single-use, non-sterile	A non-sterile, surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a single-use device.	Obsolete	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: 9 Millimeter
Length: 7 Millimeter
Length: 4 Millimeter
Outer Diameter: 400 Micrometer

Device Record Status

Public Device Record Key: 2cb0a355-883d-4ab6-bf0a-1f797f42f645
Public Version Date: June 12, 2023
Public Version Number: 3
DI Record Publish Date: December 19, 2019