Catalog Number

E3595

Brand Name

AccuVac

Version/Model Number

E3595

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

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

-

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

d6806a2e-7ab1-4639-8612-c07675a0e13f

Public Version Date

July 16, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10884524001814

Quantity per Package

10

Contains DI Package

20884524001811

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE