Instrument

FDA UDI

Class I (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: INSTRUMENT FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: SCORPIO PATELLA RECESS RASP (SIZE 11-13) LRS INSTRUMENTATION FDA UDI
Model / Reference: 8050-3151 FDA UDI
Description: SCORPIO PATELLA RECESS RASP (SIZE 11-13) LRS INSTRUMENTATION FDA UDI

Identifiers

Catalog Number: 8050-3151 FDA UDI
Primary DI / UDI-DI: 07613327239119 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Bone file/rasp, manual, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

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: Bone file/rasp, manual, reusable

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

Similar devices

Also classified as Bone file/rasp, manual, reusable.

Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
Life Instruments — Life Instrument Corporation · Class I
TALOS®-C — MEDITECH SPINE, LLC · Class II
DeGen Standard Instrumentation — Degen Medical · Class I
TiWave C Cervical Cage System — Kalitec Direct LLC · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
4WEB Medical — 4Web Medical, 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 I	Pending data

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

Manufacturer

Manufacturer: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 7c8814e6-4e05-436c-84ec-dad6299f9666 34 fields · synced May 30, 2026