True Dilatation

FDA UDI

Class II (US FDA UDI)

by Bard Peripheral Vascular

Identity

Trade Name: TRUE DILATATION FDA UDI
Generic Name: Cardiac valvuloplasty catheter FDA UDI
Device Name: TRUE™ DILATATION Balloon Valvuloplasty Catheter, 24 mm x 4.5 cm, 55 cm catheter FDA UDI
Model / Reference: T244512 FDA UDI
Description: TRUE™ DILATATION Balloon Valvuloplasty Catheter, 24 mm x 4.5 cm, 55 cm catheter FDA UDI

Identifiers

Catalog Number: T244512 FDA UDI
Primary DI / UDI-DI: 00801741097539 FDA UDI
FDA Product Code: OZT FDA UDI
GMDN Term: Cardiac valvuloplasty catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1255 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiac valvuloplasty catheter

True Dilatation by Bard Peripheral Vascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bard Peripheral Vascular

Sources (1)

FDA UDI 2728b8bb-2614-43f3-ac45-00c161762d57 36 fields · synced Jun 1, 2026