Journey Uni E0014599-10

GUDID 00885556623480

UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 LL/RM

Smith & Nephew, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00885556623480
• NIH Device Record Key: c50926b2-1f8f-4c20-ab3e-3d6abb982d71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Journey Uni
• Version Model Number: E0014599-10
• Catalog Number: E0014599-10
• 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
• 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	00885556623480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113038

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

[00885556623480]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-12-11

On-Brand Devices [Journey Uni]

• 00885556715178: 3MM & 10MM TIBIA STYLUS
• 00885556696903: JOURNEY UNI TIBIAL CUTTING GUIDE RM/LL
• 00885556696897: JOURNEY UNI TIBIAL CUTTING GUIDE LM/RL
• 00885556661482: TIBIA RESECTOR BASE - RT MED / LT LAT
• 00885556661475: TIBIA RESECTOR BASE - LT MED / RT LAT
• 00885556633311: MODULAR IMPACTOR HEAD
• 00885556633304: FIN PUNCH SZ 5-6
• 00885556633298: FIN PUNCH SZ 3-4
• 00885556633281: FIN PUNCH SZ 1-2
• 00885556633274: UNI TRIAL TIB BASE W/ FIN SLOT SZ 6 RM/LL
• 00885556633267: UNI TRIAL TIB BASE W/ FIN SLOT SZ 5 RM/LL
• 00885556633250: UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 RM/LL
• 00885556633243: UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 RM/LL
• 00885556633236: UNI TRIAL TIB BASE W/ FIN SLOT SZ 2 RM/LL
• 00885556633229: UNI TRIAL TIB BASE W/ FIN SLOT SZ 1 RM/LL
• 00885556633212: UNI TRIAL TIB BASE W/ FIN SLOT SZ 6 LM/RL
• 00885556633205: UNI TRIAL TIB BASE W/ FIN SLOT SZ 5 LM/RL
• 00885556633199: UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 LM/RL
• 00885556633182: UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 LM/RL
• 00885556633175: UNI TRIAL TIB BASE W/ FIN SLOT SZ 2 LM/RL
• 00885556633168: UNI TRIAL TIB BASE W/ FIN SLOT SZ 1 LM/RL
• 00885556623541: FIN PUNCH SZ 5-6
• 00885556623534: FIN PUNCH SZ 3-4
• 00885556623527: FIN PUNCH SZ 1-2
• 00885556623510: MODULAR IMPACTOR HEAD
• 00885556623503: UNI TRIAL TIB BASE W/ FIN SLOT SZ 6 LL/RM
• 00885556623497: UNI TRIAL TIB BASE W/ FIN SLOT SZ 5 LL/RM
• 00885556623480: UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 LL/RM
• 00885556616918: UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 LM/RL
• 00885556616901: UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 LL/RM
• 00885556616895: UNI TRIAL TIB BASE W/ FIN SLOT SZ 2 LL/RM
• 00885556616888: UNI TRIAL TIB BASE W/ FIN SLOT SZ 1 LL/RM
• 00885556616871: UNI TRIAL TIB BASE W/ FIN SLOT SZ 6 LM/RL
• 00885556616864: UNI TRIAL TIB BASE W/ FIN SLOT SZ 5 LM/RL
• 00885556616857: UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 LM/RL
• 00885556616840: UNI TRIAL TIB BASE W/ FIN SLOT SZ 2 LM/RL
• 00885556616833: UNI TRIAL TIB BASE W/ FIN SLOT SZ 1 LM/RL