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Map-iT

FDA UDI

Class II (US FDA UDI)

by Access Point Technologies, Inc.

Identity

Trade Name
Map-iT FDA UDI
Generic Name
Intracardiac catheter-tip electrode FDA UDI
Device Name
STR, 10 electrode, MPD-CS-M, 5mm electrode spacing FDA UDI
Model / Reference
903921 FDA UDI
Description
STR, 10 electrode, MPD-CS-M, 5mm electrode spacing FDA UDI

Identifiers

Catalog Number
903921 FDA UDI
Primary DI / UDI-DI
00818083018559 FDA UDI
FDA Product Code
DRF FDA UDI
GMDN Term
Intracardiac catheter-tip electrode 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 — 7 French FDA UDI
Length — 110 Centimeter FDA UDI

Category: Intracardiac catheter-tip electrode

Map-iT by Access Point Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracardiac catheter-tip electrode.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Access Point Technologies, Inc.

Sources (1)

  • FDA UDI ab55c1bc-ed42-4deb-8db6-fd8fcad8bdcf 35 fields · synced May 30, 2026