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Genesis II

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Genesis II FDA UDI
Generic Name
Osteotomy guide, reusable FDA UDI
Device Name
GII ROUND PATELLA DRILL GUIDE 35MM FDA UDI
Model / Reference
E0017159-5 FDA UDI
Description
GII ROUND PATELLA DRILL GUIDE 35MM FDA UDI

Identifiers

Catalog Number
E0017159-5 FDA UDI
Primary DI / UDI-DI
00885556796900 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Osteotomy guide, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Osteotomy guide, reusable

Genesis II by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Osteotomy guide, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 731ad2ce-3eea-43b5-b2c2-36bbcb151c75 35 fields · synced Jun 8, 2026