Ultra Drive Irrigation

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: ULTRA DRIVE IRRIGATION FDA UDI
Generic Name: Surgical power tool irrigation-control device FDA UDI
Model / Reference: 423844 FDA UDI

Identifiers

Catalog Number: 423844 FDA UDI
Primary DI / UDI-DI: 00880304372948 FDA UDI
510(k) Number: K031280 FDA UDI
K900003 FDA UDI
FDA Product Code: JXE FDA UDI
JDX FDA UDI
GMDN Term: Surgical power tool irrigation-control device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1550 FDA UDI
888.4580 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical power tool irrigation-control device

Ultra Drive Irrigation by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical power tool irrigation-control device.

ULTRA-DRIVE® — Biomet Orthopedics, Inc. · Class II
ULTRA-DRIVE® — Biomet Orthopedics, Inc. · Class II
ULTRA-DRIVE III IRRIGATION CLIP — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K900003 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

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Manufacturer

Manufacturer: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI aeb3b857-ef7b-47af-924e-d62465701630 35 fields · synced May 30, 2026