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Z2

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Z2 FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
CATHETER Z26EBU45 Z2 6F 100CM EB45 FDA UDI
Model / Reference
Z26EBU45 FDA UDI
Description
CATHETER Z26EBU45 Z2 6F 100CM EB45 FDA UDI

Identifiers

Primary DI / UDI-DI
00613994813947 FDA UDI
510(k) Number
K981198 FDA UDI
FDA Product Code
DQY FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 100.0 Centimeter FDA UDI
Catheter Gauge — 6.0 French FDA UDI

Category: Vascular guide-catheter, single-use

Z2 by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI f5c0b587-8e5c-430f-974b-6d4615fce6da 37 fields · synced Jun 8, 2026