SCANLAN® Instrumentation

FDA UDI

Class I (US FDA UDI)

by Scanlan International Inc

Identity

Trade Name: SCANLAN® Instrumentation FDA UDI
Generic Name: Heart valve annulus sizer, reusable FDA UDI
Device Name: SCANLAN® Cardiovascular Probe FDA UDI
Model / Reference: Q38042-02 FDA UDI
Description: SCANLAN® Cardiovascular Probe FDA UDI

Identifiers

Catalog Number: Q38042-02 FDA UDI
Primary DI / UDI-DI: 00846159035643 FDA UDI
FDA Product Code: DWS FDA UDI
GMDN Term: Heart valve annulus sizer, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.4500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Heart valve annulus sizer, reusable

SCANLAN® Instrumentation by Scanlan International Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heart valve annulus sizer, reusable.

Trifecta™ — ST. JUDE MEDICAL, INC. · Class I
Hancock™ II — MEDTRONIC, INC. · Class I
Tailor™ & Attune™ — ST. JUDE MEDICAL, INC. · Class I
Dafodil™ Pericardial Bioprosthesis Valve — Meril Life Sciences Pvt. Ltd. · Class III
Freestyle™ 7990 — MEDTRONIC, INC. · Class I
Medtronic Open Pivot™ — MEDTRONIC, INC. · Class I
PERCEVAL S — CORCYM SRL · Class I
Tri-Ad™ — MEDTRONIC, INC. · Class I

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Scanlan International Inc

Sources (1)

FDA UDI f88b6f7b-58c3-4fe7-acda-acec97d51800 35 fields · synced May 29, 2026