UltraShape system - UltraShape System, Packaged for US - SYNERON MEDICAL LTD

Duns Number:532685716

Device Description: UltraShape System, Packaged for US

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More Product Details

Catalog Number

FG71051USR

Brand Name

UltraShape system

Version/Model Number

FG71051USR

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141708

Product Code Details

Product Code

OHV

Product Code Name

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Device Record Status

Public Device Record Key

10d11a94-cdea-4ab5-92af-e36ab8301d54

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 25, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNERON MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 194