N/A - RFB DYONICS RF GENERATOR - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: RFB DYONICS RF GENERATOR

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More Product Details

Catalog Number

72202149F

Brand Name

N/A

Version/Model Number

72202149F

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 17, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090393

Product Code Details

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

f2c12e73-fe7e-4f3d-8f06-80d1d0849665

Public Version Date

March 18, 2022

Public Version Number

4

DI Record Publish Date

September 28, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMITH & NEPHEW, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10651
2 A medical device with a moderate to high risk that requires special controls. 35590
3 A medical device with high risk that requires premarket approval 351