ELMED - ELMED ESU 120 M/M DIGITAL SYSTEM ELECTROSURGICAL - ELMED INCORPORATED

Duns Number:049290364

Device Description: ELMED ESU 120 M/M DIGITAL SYSTEM ELECTROSURGICAL UNIT, FOOTSWITCHING SMART-O-MATIC CIRCUIT ELMED ESU 120 M/M DIGITAL SYSTEM ELECTROSURGICAL UNIT, FOOTSWITCHING SMART-O-MATIC CIRCUIT FOR MONOPOLAR, BIPOLAR AND RADIO FREQUENCY THERMAL ABLATION (RFTA) MICRO MODE, INCLUDES FOOTSWITCH

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More Product Details

Catalog Number

5797

Brand Name

ELMED

Version/Model Number

5797

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

BWA

Product Code Name

Unit, Electrosurgical Andcoagulation, With Accessories

Device Record Status

Public Device Record Key

7e2b05a3-135c-4471-9f81-e0ac680cd7d1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELMED INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 4068