NC30800T - 8.0 Fr. Silicone Urinary Collection Kit with - NEOCHILD, LLC

Duns Number:022760922

Device Description: 8.0 Fr. Silicone Urinary Collection Kit with catheter

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More Product Details

Catalog Number

-

Brand Name

NC30800T

Version/Model Number

NC30800T

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

LRO

Product Code Name

General Surgery Tray

Device Record Status

Public Device Record Key

05ec82dd-d957-41dc-8ac5-50dd743a2eb4

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

February 19, 2018

Additional Identifiers

Package DI Number

10816336021018

Quantity per Package

5

Contains DI Package

10816336020387

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"NEOCHILD, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 112