SOMA BORNÉO 30'' - Silhouet-Tone Corporation

Duns Number:242049828

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More Product Details

Catalog Number

-

Brand Name

SOMA BORNÉO 30''

Version/Model Number

412545

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

KMN

Product Code Name

Chair And Table, Medical

Device Record Status

Public Device Record Key

f12265d8-661e-4aab-99f9-8ea1772558d2

Public Version Date

September 24, 2018

Public Version Number

1

DI Record Publish Date

August 24, 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