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Inquiry™

FDA UDI

Class II (US FDA UDI)

by Irvine Biomedical, Inc.

Identity

Trade Name
Inquiry™ FDA UDI
Generic Name
Cardiac mapping catheter, percutaneous, single-use FDA UDI
Device Name
Steerable Diagnostic Catheter FDA UDI
Model / Reference
IBI-81130 FDA UDI
Description
Steerable Diagnostic Catheter FDA UDI

Identifiers

Catalog Number
IBI-81130 FDA UDI
Primary DI / UDI-DI
05414734303217 FDA UDI
FDA Product Code
DRF FDA UDI
GMDN Term
Cardiac mapping catheter, percutaneous, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1220 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
Catheter Gauge — 7 French FDA UDI
Length — 110.0000 Centimeter FDA UDI

Category: Cardiac mapping catheter, percutaneous, single-use

Inquiry™ by Irvine Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping catheter, percutaneous, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Irvine Biomedical, Inc.

Sources (1)

  • FDA UDI f5174402-f1a7-4803-ad45-fdd43bcc3157 37 fields · synced Jun 1, 2026