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Journey

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
JOURNEY FDA UDI
Generic Name
Total knee prosthesis implantation guide-instrument kit FDA UDI
Device Name
JRNY II BCS FEMORAL SIZE 9 TP KIT NO A/P FDA UDI
Model / Reference
74010124KT FDA UDI
Description
JRNY II BCS FEMORAL SIZE 9 TP KIT NO A/P FDA UDI

Identifiers

Catalog Number
74010124KT FDA UDI
Primary DI / UDI-DI
00885556304846 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Total knee prosthesis implantation guide-instrument kit 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: Total knee prosthesis implantation guide-instrument kit

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

Similar devices

Also classified as Total knee prosthesis implantation guide-instrument kit.

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 0e996cc9-2c76-40ff-82d3-cc47cee9769f 35 fields · synced Jun 8, 2026