Thora-Vent Thoracic Vent - THORA-VENT Procedure Tray - 11F 13cm - URESIL, LLC

Duns Number:192559557

Device Description: THORA-VENT Procedure Tray - 11F 13cm

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More Product Details

Catalog Number

TV11-13

Brand Name

Thora-Vent Thoracic Vent

Version/Model Number

TV11-13

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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"

Yes

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Device Record Status

Public Device Record Key

826242fd-c077-40c4-8418-617b96c8af85

Public Version Date

April 01, 2022

Public Version Number

1

DI Record Publish Date

March 24, 2022

Additional Identifiers

Package DI Number

10817640020766

Quantity per Package

1

Contains DI Package

00817640020769

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser

"URESIL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 179
2 A medical device with a moderate to high risk that requires special controls. 77
U Unclassified 24