Instrument

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: INSTRUMENT FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: CUTTING EDGE ADVANTAGE SECUR-FIT OMNIFIT EON BROACH PF4 FDA UDI
Model / Reference: 1110-0204 FDA UDI
Description: CUTTING EDGE ADVANTAGE SECUR-FIT OMNIFIT EON BROACH PF4 FDA UDI

Identifiers

Catalog Number: 1110-0204 FDA UDI
Primary DI / UDI-DI: 07613327238204 FDA UDI
FDA Product Code: KWZ FDA UDI
MBL FDA UDI
LZO FDA UDI
HWC FDA UDI
MEH FDA UDI
JDI FDA UDI
LPH FDA UDI
KWY FDA UDI
KWL FDA UDI
LWJ FDA UDI
MAY FDA UDI
GMDN Term: Orthopaedic broach FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3310 FDA UDI
888.3358 FDA UDI
888.3353 FDA UDI
888.3040 FDA UDI
888.3350 FDA UDI
888.3390 FDA UDI
888.3360 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic broach

Instrument by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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iNSitu™ Hip System — Nextstep Arthropedix · Class I
TEMA Elbow — Limacorporate · Class II
APEX Knee System — OMNIlife science, 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: Howmedica Osteonics Corp.

Sources (1)

FDA UDI ffee12ff-0419-4a48-a2b8-f607edf1060e 34 fields · synced May 30, 2026