Gen2

FDA UDI

Class II (US FDA UDI)

by Surgix Medical Llc

Identity

Trade Name: Gen2 FDA UDI
Generic Name: Suction system catheter, general-purpose FDA UDI
Device Name: TAPERED TEARDROP SUCTION TUBE 8" 9 FR FDA UDI
Model / Reference: G2N28509 FDA UDI
Description: TAPERED TEARDROP SUCTION TUBE 8" 9 FR FDA UDI

Identifiers

Catalog Number: G2N28509 FDA UDI
Primary DI / UDI-DI: 00840343706159 FDA UDI
FDA Product Code: JOL FDA UDI
GMDN Term: Suction system catheter, general-purpose FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6740 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

Yes

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 — 8 Inch FDA UDI
Catheter Gauge — 9 French FDA UDI

Category: Suction system catheter, general-purpose

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

Similar devices

Also classified as Suction system catheter, general-purpose.

Integra® Ruggles®-Redmond™ — Integra LifeSciences Production Corporation · Class II
Hayden Medical — Hayden Medical Inc · Class II
GP General Purpose Drainage Catheter — Uresil Corp. · Class I
Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Ballard* Multi-Access Port Closed Suction System — Avanos Medical, Inc. · Class I

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 84ff33b5-dcb0-44c4-917a-e18e54a3780a 36 fields · synced Jun 8, 2026