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Journey Ii Fastpak

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
JOURNEY II FASTPAK FDA UDI
Generic Name
Knee tibia prosthesis trial, single-use FDA UDI
Device Name
JOURNEY II FASTPAK SIZE 1-2 RIGHT INSERT TRIALS AND SPACERS 9-13,15 MM FDA UDI
Model / Reference
74012012 FDA UDI
Description
JOURNEY II FASTPAK SIZE 1-2 RIGHT INSERT TRIALS AND SPACERS 9-13,15 MM FDA UDI

Identifiers

Catalog Number
74012012 FDA UDI
Primary DI / UDI-DI
00885556808382 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Knee tibia prosthesis trial, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Knee tibia prosthesis trial, single-use

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

Similar devices

Also classified as Knee tibia prosthesis trial, single-use.

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 8293a982-b73d-4d0b-9468-304843e1d676 35 fields · synced Jun 8, 2026