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Micro-Access Elite HV Catheter Introducer Set

FDA UDI

Class II (US FDA UDI)

by Galt Medical Corp.

Identity

Trade Name
Micro-Access Elite HV Catheter Introducer Set FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
Micro-Access Elite HV Catheter Introducer Set FDA UDI
Model / Reference
CLI-110-70 FDA UDI
Description
Micro-Access Elite HV Catheter Introducer Set FDA UDI

Identifiers

Catalog Number
CLI-110-70 FDA UDI
Primary DI / UDI-DI
00841268102798 FDA UDI
FDA Product Code
OFL FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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 — 4 French FDA UDI

Category: Vascular catheter introduction set, nonimplantable

Micro-Access Elite HV Catheter Introducer Set by Galt Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

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 d0b9af2f-9d43-4e6c-93c0-7098e6878db9 36 fields · synced May 30, 2026