Diode Laser Tips - A tip kit containing 30 single-use laser tips - BIOLASE, INC.

Duns Number:152165700

Device Description: A tip kit containing 30 single-use laser tips intended for use with diode laser systems. T A tip kit containing 30 single-use laser tips intended for use with diode laser systems. The tips have the same core diameter of 400 microns and vary in length.

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More Product Details

Catalog Number

7400019

Brand Name

Diode Laser Tips

Version/Model Number

Perio EZ Tips Combo Pack, E4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K121286

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

ec5d6cf1-702c-4896-8003-d50b2fdab862

Public Version Date

July 29, 2020

Public Version Number

6

DI Record Publish Date

October 11, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOLASE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 155