EVOLUTION 7HD SEQUENTIAL - Silhouet-Tone Corporation

Duns Number:242049828

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More Product Details

Catalog Number

-

Brand Name

EVOLUTION 7HD SEQUENTIAL

Version/Model Number

411017

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

-

Product Code Details

Product Code

KCW

Product Code Name

Epilator, High Frequency, Needle-Type

Device Record Status

Public Device Record Key

90e9fead-56be-4d44-859f-450025a2867a

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 17, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SILHOUET-TONE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 52
2 A medical device with a moderate to high risk that requires special controls. 3