← Back to catalogue

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
Model / Reference
UL-QD500 FDA UDI

Identifiers

Catalog Number
UL-QD500 FDA UDI
Primary DI / UDI-DI
00889024465909 FDA UDI
510(k) Number
K123188 FDA UDI
K133786 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

Yes

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

No

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

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

Manufacturer

Manufacturer
Dornoch Medical Systems, Inc.

Sources (1)

  • FDA UDI f46cafea-6a14-4956-b034-ed022811cea5 35 fields · synced Jun 1, 2026