Catalog Number

PMI52-205100

Brand Name

ELMED

Version/Model Number

PMI52-205100

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

HIN

Product Code Name

Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)

Public Device Record Key

13a0157f-4cab-4621-92c1-12d39d94cd13

Public Version Date

November 25, 2019

Public Version Number

1

DI Record Publish Date

November 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-