Catalog Number

R-10005

Brand Name

Dynablator™

Version/Model Number

R-10005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K162770,K162770

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

419817b5-9cf2-4b55-ad0e-c0b061bf810e

Public Version Date

January 06, 2021

Public Version Number

3

DI Record Publish Date

February 20, 2020

Package DI Number

10859273007059

Quantity per Package

4

Contains DI Package

00859273007052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box