Laguna Mist Flex with Armrest 230V - Silhouet-Tone Corporation

Duns Number:242049828

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More Product Details

Catalog Number

412004

Brand Name

Laguna Mist Flex with Armrest 230V

Version/Model Number

412004

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

207625e4-1eff-4dbf-b27f-51bb37243b94

Public Version Date

July 11, 2019

Public Version Number

4

DI Record Publish Date

June 16, 2017

Additional Identifiers

Package DI Number

00667259000443

Quantity per Package

1

Contains DI Package

00667259000030

Package Discontinue Date

July 10, 2019

Package Status

Not in Commercial Distribution

Package Type

skid

"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