Gen2

FDA UDI

Class II (US FDA UDI)

by Surgix Medical Llc

Identity

Trade Name: GEN2 FDA UDI
Generic Name: Vascular dilator, reusable FDA UDI
Device Name: GARRETT VASCULAR DILATOR 1.5MM 14CM 5-1/2" FDA UDI
Model / Reference: G2C52052 FDA UDI
Description: GARRETT VASCULAR DILATOR 1.5MM 14CM 5-1/2" FDA UDI

Identifiers

Catalog Number: G2C52052 FDA UDI
Primary DI / UDI-DI: 00840343704292 FDA UDI
510(k) Number: K163524 FDA UDI
FDA Product Code: DWP FDA UDI
GMDN Term: Vascular dilator, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4475 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 5.5 Inch FDA UDI

Category: Vascular dilator, reusable

Gen2 by Surgix Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K163524 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Surgix Medical Llc

Sources (1)

FDA UDI 0d57c1b0-6ba7-49d3-9056-98be6df2ebb2 37 fields · synced May 30, 2026