NICO Myriad - Specimen Collector with Filter Element - Clamshell - NICO CORPORATION

Duns Number:829838288

Device Description: Specimen Collector with Filter Element - Clamshell

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More Product Details

Catalog Number

-

Brand Name

NICO Myriad

Version/Model Number

NN-9002

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)

Yes

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

FMH

Product Code Name

Container, Specimen, Sterile

Device Record Status

Public Device Record Key

58c8e020-75c9-4ade-92e2-09491eb13324

Public Version Date

October 08, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

10816744029026

Quantity per Package

5

Contains DI Package

00816744029029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"NICO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 62