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Amplatzer™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
Amplatzer™ FDA UDI
Generic Name
Cardiac sizing catheter FDA UDI
Device Name
Sizing Balloon II FDA UDI
Model / Reference
9-SB-018 FDA UDI
Description
Sizing Balloon II FDA UDI

Identifiers

Catalog Number
9-SB-018 FDA UDI
Primary DI / UDI-DI
00811806011516 FDA UDI
FDA Product Code
MJN FDA UDI
GMDN Term
Cardiac sizing catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 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

Dimensions & Sizes

Size
Length — 70.0000 Centimeter FDA UDI
Outer Diameter — 18.0000 Millimeter FDA UDI

Category: Cardiac sizing catheter

Amplatzer™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac sizing catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI f1229475-f7c1-47e6-98dc-6d50a6074b5e 37 fields · synced May 31, 2026