JUK E0015229-1

GUDID 00885556673836

JOURNEY UNI LATERAL SIZING TEMPLATE SZ 0-1

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00885556673836
• NIH Device Record Key: 1a3d63fc-0fb6-4e6f-8598-b8af30677d97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JUK
• Version Model Number: E0015229-1
• Catalog Number: E0015229-1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556673836 [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

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

[00885556673836]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-19

On-Brand Devices [JUK]

• 00885556673867: JOURNEY UNI LATERAL SIZING TEMPLATE SZ 6-7
• 00885556673850: JOURNEY UNI LATERAL SIZING TEMPLATE SZ 4-5
• 00885556673843: JOURNEY UNI LATERAL SIZING TEMPLATE SZ 2-3
• 00885556673836: JOURNEY UNI LATERAL SIZING TEMPLATE SZ 0-1