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Journey II

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Journey II FDA UDI
Generic Name
Knee tibia prosthesis trial, reusable FDA UDI
Device Name
DEEP DISH TRIAL INSERT 5-6 10MM RIGHT FDA UDI
Model / Reference
E0014931-14 FDA UDI
Description
DEEP DISH TRIAL INSERT 5-6 10MM RIGHT FDA UDI

Identifiers

Catalog Number
E0014931-14 FDA UDI
Primary DI / UDI-DI
00885556646212 FDA UDI
510(k) Number
K113482 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Knee tibia prosthesis trial, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
Commercial Distribution
Not 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

No

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

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

Cleared under the same submission

K113482 also covers:

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 7f6721f3-1bfe-49dd-83a8-0d92508982ca 37 fields · synced Jun 8, 2026