Catalog Number

5988

Brand Name

ELMED

Version/Model Number

5988

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

BWA

Product Code Name

Unit, Electrosurgical Andcoagulation, With Accessories

Public Device Record Key

dc22cc63-ebf9-4052-b831-90d8f81ac407

Public Version Date

March 14, 2019

Public Version Number

1

DI Record Publish Date

March 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-