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Zinger® Support

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
ZINGER® SUPPORT FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
GDWR ZNGRS300HS ZINGERS 5PK 300 ST HY FDA UDI
Model / Reference
ZNGRS300HS FDA UDI
Description
GDWR ZNGRS300HS ZINGERS 5PK 300 ST HY FDA UDI

Identifiers

Primary DI / UDI-DI
00643169452534 FDA UDI
510(k) Number
K140695 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Cardiac/peripheral vascular guidewire, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 FDA UDI
Commercial Distribution
Not 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 — 300.0 Centimeter FDA UDI
Outer Diameter — 0.014 Inch FDA UDI

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

Cleared under the same submission

K140695 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI d4d6d8cb-0e24-4ef9-9476-e1df9dc1f06e 38 fields · synced May 31, 2026