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Galt Medical Guidewiregalt Medical Guidewire

FDA UDI

Class II (US FDA UDI)

by Medical Components Inc

Identity

Trade Name
GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIRE FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
0.010" (0.26MM) X 40CM0.010" (0. NITINOL GUIDEWIRENITINOL GUIDEWI FDA UDI
Model / Reference
MR190040 FDA UDI
Description
0.010" (0.26MM) X 40CM0.010" (0. NITINOL GUIDEWIRENITINOL GUIDEWI FDA UDI

Identifiers

Primary DI / UDI-DI
00884908105278 FDA UDI
510(k) Number
K021990 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

Yes

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

Galt Medical Guidewiregalt Medical Guidewire by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K021990 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Components Inc

Sources (1)

  • FDA UDI f5dce1f5-4f3e-48d8-9edb-24d9c34efb67 36 fields · synced May 30, 2026