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AVID TruCustom

FDA UDI

Class II (US FDA UDI)

by Avid Medical, Inc.

Identity

Trade Name
AVID TruCustom FDA UDI
Generic Name
Cardiothoracic surgical procedure kit, medicated, single-use FDA UDI
Model / Reference
ADCO001-10_0001 FDA UDI

Identifiers

Catalog Number
ADCO001-10 FDA UDI
Primary DI / UDI-DI
10809160043523 FDA UDI
FDA Product Code
OEZ FDA UDI
GMDN Term
Cardiothoracic surgical procedure kit, medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Cardiothoracic surgical procedure kit, medicated, single-use

AVID TruCustom by Avid Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiothoracic surgical procedure kit, medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avid Medical, Inc.

Sources (1)

  • FDA UDI d71c29a8-e8c8-4aa2-810d-23b2f94bf2af 34 fields · synced Jun 8, 2026