Precise LTM 60° Tip - Single-use 60° angled handpiece tip for use with - CAO GROUP, INC.

Duns Number:102422578

Device Description: Single-use 60° angled handpiece tip for use with the Precise LTM Diode Laser.

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More Product Details

Catalog Number

-

Brand Name

Precise LTM 60° Tip

Version/Model Number

00669

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062619,K062619,K062619

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

e742f619-9bcf-427b-9964-6f27123c80e9

Public Version Date

November 08, 2018

Public Version Number

5

DI Record Publish Date

November 10, 2016

Additional Identifiers

Package DI Number

00872320003135

Quantity per Package

20

Contains DI Package

00872320003449

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack

"CAO GROUP, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 51