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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
SPECIALTY TRIDENT ACETABULAR HIGH RIM REAMER FDA UDI
Model / Reference
I-H0659HA54 FDA UDI
Description
SPECIALTY TRIDENT ACETABULAR HIGH RIM REAMER FDA UDI

Identifiers

Catalog Number
I-H0659HA54 FDA UDI
Primary DI / UDI-DI
07613327319798 FDA UDI
FDA Product Code
LZO FDA UDI
MEH FDA UDI
HWC FDA UDI
LPH FDA UDI
KWL FDA UDI
KWY FDA UDI
LWJ FDA UDI
MAY FDA UDI
JDI FDA UDI
MBL FDA UDI
KWZ FDA UDI
GMDN Term
Acetabular orthopaedic reamer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
888.3040 FDA UDI
888.3358 FDA UDI
888.3360 FDA UDI
888.3390 FDA UDI
888.3350 FDA UDI
888.3310 FDA UDI
Commercial Distribution
Not 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

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Howmedica Osteonics Corp.

Sources (1)

  • FDA UDI 469989fd-27b3-43c0-b739-40020f95d71d 36 fields · synced Jun 8, 2026