InSure® ONE™ - InSure® ONE™ Test Cards for QC - 50 pack - ENTERIX INC.

Duns Number:002224009

Device Description: InSure® ONE™ Test Cards for QC - 50 pack

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More Product Details

Catalog Number

11018.01

Brand Name

InSure® ONE™

Version/Model Number

01

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

K170548

Product Code Details

Product Code

KHE

Product Code Name

Reagent, Occult Blood

Device Record Status

Public Device Record Key

e0caaf68-9b44-477e-a005-f872d5110b1b

Public Version Date

April 06, 2020

Public Version Number

4

DI Record Publish Date

January 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENTERIX INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12