Silicone Thoracic Catheters - 9mm Mediastinal – Silicone Catheter - Atrium Medical Corporation

Duns Number:051798999

Device Description: 9mm Mediastinal – Silicone Catheter

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More Product Details

Catalog Number

14809

Brand Name

Silicone Thoracic Catheters

Version/Model Number

14809

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

KGZ

Product Code Name

Accessories, Catheter

Device Record Status

Public Device Record Key

63e215db-3744-4818-9fcc-a9fbbcbb46ab

Public Version Date

October 15, 2020

Public Version Number

2

DI Record Publish Date

September 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ATRIUM MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 161
2 A medical device with a moderate to high risk that requires special controls. 273