Catalog Number

-

Brand Name

Delasco 734 Handpiece

Version/Model Number

734/H

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

92aceb5e-ac19-41d9-974c-728b25225eba

Public Version Date

June 21, 2018

Public Version Number

4

DI Record Publish Date

May 13, 2016

Package DI Number

10609960000197

Quantity per Package

10

Contains DI Package

00609960000190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case