Instrument

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: INSTRUMENT FDA UDI
Generic Name: Acetabular orthopaedic reamer FDA UDI
Device Name: CUTTING EDGE ACETABULAR SPHERICAL REAMER FDA UDI
Model / Reference: 2102-0465 FDA UDI
Description: CUTTING EDGE ACETABULAR SPHERICAL REAMER FDA UDI

Identifiers

Catalog Number: 2102-0465 FDA UDI
Primary DI / UDI-DI: 07613327211955 FDA UDI
FDA Product Code: MAY FDA UDI
JDI FDA UDI
MBL FDA UDI
KWZ FDA UDI
LZO FDA UDI
MEH FDA UDI
LWJ FDA UDI
HWC FDA UDI
KWY FDA UDI
LPH FDA UDI
KWL FDA UDI
GMDN Term: Acetabular orthopaedic reamer FDA UDI

Classification

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

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

Similar devices

Also classified as Acetabular orthopaedic reamer.

Acetabular Reamer Driver, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
Viant Medical, LLC — Viant Medical, LLC · Class I
ACETABULAR REAMER D53 mm HC — HPF SRL · Class I
Flexible Reamer Ø14 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class I
Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD · Class II
ACETABULAR REAMER D82 mm HC — HPF SRL · Class I
iTotal® Hip Replacement System — Conformis, Inc. · Class II
M.B.T. — DePuy Ireland UC · Class IIa

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

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

Manufacturer

Manufacturer: Howmedica Osteonics Corp.

Sources (1)

FDA UDI c48acca7-5d40-4416-8903-debd56a382a7 35 fields · synced May 30, 2026