Work Inc. - WORK INCORPORATED

Duns Number:079523064

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More Product Details

Catalog Number

-

Brand Name

Work Inc.

Version/Model Number

2049

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 18, 2020

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

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

bcbd0dd0-4fdb-45ee-9211-8bbe0d138f8d

Public Version Date

July 15, 2020

Public Version Number

4

DI Record Publish Date

August 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WORK INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1