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Millennium

FDA UDI

Class II (US FDA UDI)

by AVALIGN TECHNOLOGIES, Inc.

Identity

Trade Name
Millennium FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Device Name
BIPOL IN SCO-GREEN 1.5T 7.75" FDA UDI
Model / Reference
100-S03443R FDA UDI
Description
BIPOL IN SCO-GREEN 1.5T 7.75" FDA UDI

Identifiers

Primary DI / UDI-DI
00190776129729 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Millennium by AVALIGN TECHNOLOGIES, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
AVALIGN TECHNOLOGIES, Inc.

Sources (1)

  • FDA UDI be4487b3-e809-43cc-837d-34e983832f9a 34 fields · synced May 31, 2026