Accu-Beam - 5mm x 27.4cm Cannula with Holes. - TRANSAMERICAN TECHNOLOGIES INTERNATIONAL

Duns Number:130213366

Device Description: 5mm x 27.4cm Cannula with Holes.

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More Product Details

Catalog Number

-

Brand Name

Accu-Beam

Version/Model Number

9451L

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

K910978

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

0c8d1214-aaea-43c9-9ac5-b1a63681df13

Public Version Date

August 21, 2019

Public Version Number

5

DI Record Publish Date

July 13, 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