Accu-Beam - Topcon LED Illumination upgrade. Continuous wave - TRANSAMERICAN TECHNOLOGIES INTERNATIONAL

Duns Number:130213366

Device Description: Topcon LED Illumination upgrade. Continuous wave only.

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More Product Details

Catalog Number

-

Brand Name

Accu-Beam

Version/Model Number

LED-TC-CW

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

-

Product Code Details

Product Code

KEG

Product Code Name

Lamps, Microscope

Device Record Status

Public Device Record Key

a6d268bb-ba4f-48dc-8b7a-09747dc219aa

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

August 28, 2018

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