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Radial Artery Access Introducer Set

FDA UDI

Class II (US FDA UDI)

by Galt Medical Corp.

Identity

Trade Name
Radial Artery Access Introducer Set FDA UDI
Generic Name
Haemostasis valve FDA UDI
Device Name
Radial Artery Access Introducer Set FDA UDI
Model / Reference
CLI-423-07 FDA UDI
Description
Radial Artery Access Introducer Set FDA UDI

Identifiers

Catalog Number
CLI-423-07 FDA UDI
Primary DI / UDI-DI
00841268104105 FDA UDI
510(k) Number
K043525 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Haemostasis valve FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 7 French FDA UDI

Radial Artery Access Introducer Set by Galt Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K043525 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Galt Medical Corp.

Sources (1)

  • FDA UDI c771c9fe-ed92-46aa-98f6-2b6eb9ea22d8 38 fields · synced May 31, 2026