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UltrafleX Quad

FDA UDI

Class II (US FDA UDI)

by Dornoch Medical Systems, Inc.

Identity

Trade Name
UltrafleX Quad FDA UDI
Generic Name
Surgical fluid/smoke waste management system suction unit FDA UDI
Device Name
ULTRAFLEX QUAD HIGH FLUID CART WITH SMOKE EVACUATOR FDA UDI
Model / Reference
UL-QD500SE FDA UDI
Description
ULTRAFLEX QUAD HIGH FLUID CART WITH SMOKE EVACUATOR FDA UDI

Identifiers

Catalog Number
UL-QD500SE FDA UDI
Primary DI / UDI-DI
00889024465923 FDA UDI
FDA Product Code
JCX FDA UDI
GMDN Term
Surgical fluid/smoke waste management system suction unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical fluid/smoke waste management system suction unit

UltrafleX Quad by Dornoch Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical fluid/smoke waste management system suction unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dornoch Medical Systems, Inc.

Sources (1)

  • FDA UDI 1de2f513-54e0-4ad4-bcbd-fbfa9fbbbe1c 35 fields · synced May 30, 2026