Laguna Mist 29' 230V - Silhouet-Tone Corporation

Duns Number:242049828

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More Product Details

Catalog Number

412002

Brand Name

Laguna Mist 29' 230V

Version/Model Number

412002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 10, 2019

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

LGX

Product Code Name

Table, Examination, Medical, Powered

Device Record Status

Public Device Record Key

9b9efa61-928f-44d1-9d9b-15d3e8cf5218

Public Version Date

July 11, 2019

Public Version Number

4

DI Record Publish Date

June 16, 2017

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