Laguna Nigel 32'' 230v - Silhouet-Tone Corporation

Duns Number:242049828

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More Product Details

Catalog Number

412031

Brand Name

Laguna Nigel 32'' 230v

Version/Model Number

412031

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 13, 2018

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

d79683f7-4171-4a77-8559-51d15198e49c

Public Version Date

August 14, 2018

Public Version Number

3

DI Record Publish Date

July 18, 2017

Additional Identifiers

Package DI Number

00667259000504

Quantity per Package

1

Contains DI Package

00667259000092

Package Discontinue Date

August 13, 2018

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