Lingraphica - Speech Generating Device - Lenovo Tab 4 - 10" - Lingraphicare America, Inc.

Duns Number:053502436

Device Description: Speech Generating Device - Lenovo Tab 4 - 10"

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More Product Details

Catalog Number

-

Brand Name

Lingraphica

Version/Model Number

TouchTalk

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

Yes

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

ILQ

Product Code Name

System, Communication, Powered

Device Record Status

Public Device Record Key

d90a357a-4ede-4efb-b15b-f8584c8f5ea6

Public Version Date

August 01, 2022

Public Version Number

1

DI Record Publish Date

July 22, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LINGRAPHICARE AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 20