Journey II E0016340-16

GUDID 00885556738795

JII CR TRIAL INSERT SZ 7-8 12MM L

Smith & Nephew, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00885556738795
• NIH Device Record Key: ce5ab43c-cd93-4441-bd83-c2f725da33b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Journey II
• Version Model Number: E0016340-16
• Catalog Number: E0016340-16
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556738795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121443

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

[00885556738795]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-06

On-Brand Devices [Journey II]

• 00885556741665: TIBIAL BLOCK - RIGHT
• 00885556741658: TIBIAL BLOCK - LEFT
• 00885556741375: TIBIAL STEM STEP REAMER - 14MM
• 00885556741368: 2MM RECUT BLOCK
• 00885556740453: ANKLE CLAMP
• 00885556740446: MICRO ALIGNMENT GUIDE
• 00885556740439: MACRO ALIGNMENT GUIDE
• 00885556739808: 2MM TIBIAL BLOCK SHIM - RIGHT
• 00885556739778: 2MM TIBIAL BLOCK SHIM - LEFT
• 00885556739679: 2MM RECUT BLOCK
• 00885556739372: MEDIAL PLUS FIN PUNCH - SZ 7-8 R
• 00885556739365: MEDIAL PLUS FIN PUNCH - SZ 7-8 L
• 00885556739358: MEDIAL PLUS FIN PUNCH - SZ 5-6 R
• 00885556739341: MEDIAL PLUS FIN PUNCH - SZ 5-6 L
• 00885556739334: MEDIAL PLUS FIN PUNCH - SZ 3-4 R
• 00885556739327: MEDIAL PLUS FIN PUNCH - SZ 3-4 L
• 00885556739310: MEDIAL PLUS FIN PUNCH - SZ 1-2 R
• 00885556739303: MEDIAL PLUS FIN PUNCH - SZ 1-2 L
• 00885556739273: JII CR TRIAL INSERT SZ 1-2 9MM L
• 00885556739150: MODIFIED HOHMANN RETRACTOR
• 00885556739143: JII CR TRIAL INSERT SZ 7-8 12MM R
• 00885556739136: JII CR TRIAL INSERT SZ 7-8 11MM
• 00885556739129: JII CR TRIAL INSERT SZ 7-8 10MM R
• 00885556739112: JII CR TRIAL INSERT SZ 5-6 12MM R
• 00885556739105: JII CR TRIAL INSERT SZ 5-6 11MM R
• 00885556739099: JII CR TRIAL INSERT SZ 5-6 10MM R
• 00885556739082: JII CR TRIAL INSERT SZ 3-4 12MM R
• 00885556739075: JII CR TRIAL INSERT SZ 3-4 11MM R
• 00885556739068: JII CR TRIAL INSERT SZ 3-4 10MM R
• 00885556739051: JII CR TRIAL INSERT SZ 1-2 12MM R
• 00885556739044: JII CR TRIAL INSERT SZ 1-2 11MM R
• 00885556739037: JII CR TRIAL INSERT SZ 1-2 10MM R
• 00885556739013: JII CR TRIAL INSERT SZ 5-6 9MM R
• 00885556738993: JII CR TRIAL INSERT SZ 1-2 9MM R
• 00885556738801: INSERTION HANDLE
• 00885556738795: JII CR TRIAL INSERT SZ 7-8 12MM L
• 00885556738788: JII CR TRIAL INSERT SZ 7-8 11MM L
• 00885556738771: JII CR TRIAL INSERT SZ 7-8 10MM L
• 00885556738764: JII CR TRIAL INSERT SZ 5-6 12MM L
• 00885556738757: JII CR TRIAL INSERT SZ 5-6 11MM L
• 00885556738740: JII CR TRIAL INSERT SZ 5-6 10MM L
• 00885556738733: JII CR TRIAL INSERT SZ 3-4 12MM L
• 00885556738726: JII CR TRIAL INSERT SZ 3-4 11MM L
• 00885556738719: JII CR TRIAL INSERT SZ 3-4 10MM L
• 00885556738702: JII CR TRIAL INSERT SZ 1-2 12MM L
• 00885556738696: JII CR TRIAL INSERT SZ 1-2 11MM L
• 00885556738689: JII CR TRIAL INSERT SZ 1-2 10MM L
• 00885556738672: JII CR TRIAL INSERT SZ 7-8 9MM L
• 00885556738665: JII CR TRIAL INSERT SZ 5-6 9MM L
• 00885556738658: JII CR TRIAL INSERT SZ 3-4 9MM L