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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
Bone-coring punch, reusable FDA UDI
Device Name
GII REVISION TIB FIN PUNCH SZ 7-8 FDA UDI
Model / Reference
71451100 FDA UDI
Description
GII REVISION TIB FIN PUNCH SZ 7-8 FDA UDI

Identifiers

Catalog Number
71451100 FDA UDI
Primary DI / UDI-DI
00885556033821 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Bone-coring punch, reusable 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone-coring punch, reusable

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

Similar devices

Also classified as Bone-coring punch, 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 a01e7e2b-1892-4402-b979-cee5a26fc87b 35 fields · synced Jun 8, 2026