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Definition

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name
Definition FDA UDI
Generic Name
Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI
Device Name
Modified Distal Centralizer FDA UDI
Model / Reference
6265-4-517 FDA UDI
Description
Modified Distal Centralizer FDA UDI

Identifiers

Catalog Number
6265-4-517 FDA UDI
Primary DI / UDI-DI
07613327035995 FDA UDI
FDA Product Code
LPH FDA UDI
LZO FDA UDI
JDI FDA UDI
MBL FDA UDI
LWJ FDA UDI
MEH FDA UDI
MAY FDA UDI
KWL FDA UDI
KWY FDA UDI
KWZ FDA UDI
GMDN Term
Polymer orthopaedic cement restrictor, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3358 FDA UDI
888.3353 FDA UDI
888.3350 FDA UDI
888.3360 FDA UDI
888.3390 FDA UDI
888.3310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Category: Polymer orthopaedic cement restrictor, non-bioabsorbable

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

Similar devices

Also classified as Polymer orthopaedic cement restrictor, non-bioabsorbable.

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 c4cc3bdf-1096-4286-9a46-c8fb7da80dab 35 fields · synced Jun 8, 2026