SOS Malleable Stylet, Adult, Green Line with Stop - SOS Malleable Stylet, Adult, Green Line with Stop - CLARUS MEDICAL, LLC

Duns Number:010316284

Device Description: SOS Malleable Stylet, Adult, Green Line with Stop

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More Product Details

Catalog Number

30000-GLS

Brand Name

SOS Malleable Stylet, Adult, Green Line with Stop

Version/Model Number

30000-GLS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

EOB

Product Code Name

Nasopharyngoscope (Flexible Or Rigid)

Device Record Status

Public Device Record Key

0720cead-5cc2-4684-ae28-0fd857fadec1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLARUS MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 22