Accu-Beam - Zeiss Pico adapter for micromanipulators. - TRANSAMERICAN TECHNOLOGIES INTERNATIONAL

Duns Number:130213366

Device Description: Zeiss Pico adapter for micromanipulators.

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More Product Details

Catalog Number

-

Brand Name

Accu-Beam

Version/Model Number

7021

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

K864378

Product Code Details

Product Code

HHR

Product Code Name

Laser, Surgical, Gynecologic

Device Record Status

Public Device Record Key

bad43a3b-f40c-4d61-8450-01c8b07e5cad

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 06, 2016

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