Accu-Beam - Kit of 13 Weighted Fiber Handpieces. Included - TRANSAMERICAN TECHNOLOGIES INTERNATIONAL

Duns Number:130213366

Device Description: Kit of 13 Weighted Fiber Handpieces. Included UDIs are:+B17710597800+B17710597810+B1771059 Kit of 13 Weighted Fiber Handpieces. Included UDIs are:+B17710597800+B17710597810+B17710597820+B17710597830+B17710597840+B17710597850+B17710597860+B17710597870+B17710597880+B17710597890+B17710597900+B17710597920+B17710597930

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Accu-Beam

Version/Model Number

FOR-9702

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K952006

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

67ea08cb-7eaa-4049-97dd-2261751385df

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

May 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRANSAMERICAN TECHNOLOGIES INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 134
2 A medical device with a moderate to high risk that requires special controls. 303