← Back to catalogue

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
Model / Reference
IBI-81107 FDA UDI

Identifiers

Catalog Number
IBI-81107 FDA UDI
Primary DI / UDI-DI
05414734303002 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

Yes

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 6 French 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

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

Manufacturer

Manufacturer
Irvine Biomedical, Inc.

Sources (1)

  • FDA UDI 6ff8ce08-a05c-490f-a5ee-75cde215f6c4 36 fields · synced Jun 1, 2026