Diode Laser Tips - An assortment kit containing 30 single-use - BIOLASE, INC.

Duns Number:152165700

Device Description: An assortment kit containing 30 single-use pre-initiated tips intended for use with diode An assortment kit containing 30 single-use pre-initiated tips intended for use with diode laser delivery systems. The tips vary in length and core diameter.

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More Product Details

Catalog Number

6400564

Brand Name

Diode Laser Tips

Version/Model Number

EpiTips Surgical Assortment

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 19, 2016

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

c5dc6343-7e04-4a2c-b48d-d6791370ae60

Public Version Date

July 29, 2020

Public Version Number

6

DI Record Publish Date

September 22, 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