THORA-CATH - DRAINAGE CATHETER - 12 FRENCH, A Silicone Chest - UTAH MEDICAL PRODUCTS, INC.

Duns Number:094651270

Device Description: DRAINAGE CATHETER - 12 FRENCH, A Silicone Chest Drainage Catheter with Trocar

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More Product Details

Catalog Number

4141209

Brand Name

THORA-CATH

Version/Model Number

12 French

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"

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

K941232,K941232

Product Code Details

Product Code

JOL

Product Code Name

Catheter And Tip, Suction

Device Record Status

Public Device Record Key

a7bc6b1d-0cc4-4ea2-a28d-7cc1d5219a5c

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

H67141412091

Quantity per Package

10

Contains DI Package

H67141412090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"UTAH MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 274