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Thoraguard

FDA UDI

Class II (US FDA UDI)

by Centese, Inc.

Identity

Trade Name
Thoraguard FDA UDI
Generic Name
Surgical suction system collection container, single-use FDA UDI
Device Name
Thoraguard Drainage Kit FDA UDI
Model / Reference
FGS-1125 FDA UDI
Description
Thoraguard Drainage Kit FDA UDI

Identifiers

Catalog Number
TGDK110012 FDA UDI
Primary DI / UDI-DI
00860000436410 FDA UDI
510(k) Number
K181667 FDA UDI
FDA Product Code
BTA FDA UDI
GMDN Term
Surgical suction system collection container, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Category: Surgical suction system collection container, single-use

Thoraguard by Centese, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical suction system collection container, single-use.

Cleared under the same submission

K181667 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Centese, Inc.

Sources (1)

  • FDA UDI 7fe52e6f-3703-4f88-af79-e4055635de2f 36 fields · synced May 30, 2026