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Stiffen Micro-Introducer Kit

FDA UDI

Class II (US FDA UDI)

by Galt Medical Corp.

Identity

Trade Name
Stiffen Micro-Introducer Kit FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
Stiffen Micro-Introducer Kit FDA UDI
Model / Reference
KIT-076-00 FDA UDI
Description
Stiffen Micro-Introducer Kit FDA UDI

Identifiers

Catalog Number
KIT-076-00 FDA UDI
Primary DI / UDI-DI
00841268107366 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

Stiffen Micro-Introducer Kit 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 eb469602-5b94-41a2-a083-06b65d1be06a 36 fields · synced May 30, 2026