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 3.5MM 14CM 5-1/2" FDA UDI
Model / Reference: G2C52056 FDA UDI
Description: GARRETT VASCULAR DILATOR 3.5MM 14CM 5-1/2" FDA UDI

Identifiers

Catalog Number: G2C52056 FDA UDI
Primary DI / UDI-DI: 00840343704339 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

Similar devices

Also classified as Vascular dilator, reusable.

Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
Novo Surgical — NOVO SURGICAL, INC. · Class II
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
HNM MEDICAL — HNM STAINLESS, LLC. · Class I
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Surgix Medical Llc

Sources (1)

FDA UDI 82d3db65-d374-4bff-b0b7-bbff2e45d922 37 fields · synced May 31, 2026