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Distal Canal Sizer

FDA UDI

Class I (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
DISTAL CANAL SIZER FDA UDI
Generic Name
Orthopaedic cement restrictor sizer FDA UDI
Model / Reference
31-479814 FDA UDI

Identifiers

Catalog Number
31-479814 FDA UDI
Primary DI / UDI-DI
00880304320055 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic cement restrictor sizer 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic cement restrictor sizer

Distal Canal Sizer by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic cement restrictor sizer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI f7cfeb20-cf9a-4f4b-baf2-8acdf3c0c905 34 fields · synced May 29, 2026