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Thora-Cath

FDA UDI

Class II (US FDA UDI)

by Utah Medical Products, Inc.

Identity

Trade Name
THORA-CATH FDA UDI
Generic Name
Mediastinal drainage catheter, non-antimicrobial FDA UDI
Device Name
DRAINAGE CATHETER - 14 FRENCH, A Silicone Chest Drainage Catheter with Trocar FDA UDI
Model / Reference
14 French FDA UDI
Description
DRAINAGE CATHETER - 14 FRENCH, A Silicone Chest Drainage Catheter with Trocar FDA UDI

Identifiers

Catalog Number
4141409 FDA UDI
Primary DI / UDI-DI
H67141414090 FDA UDI
510(k) Number
K941232 FDA UDI
FDA Product Code
JOL FDA UDI
GMDN Term
Mediastinal drainage catheter, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6740 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 14 French FDA UDI

Category: Mediastinal drainage catheter, non-antimicrobial

Thora-Cath by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mediastinal drainage catheter, non-antimicrobial.

Cleared under the same submission

K941232 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Utah Medical Products, Inc.

Sources (1)

  • FDA UDI c372ca9e-2e8e-480b-83e9-03cf38a7266b 37 fields · synced Jun 9, 2026