Joureny II E0016495-2

GUDID 00885556751589

ANKLE CLAMP

Smith & Nephew, Inc.

Bone approximation clamp

• Primary Device ID: 00885556751589
• NIH Device Record Key: 7dca2973-7f9b-4130-a2c2-73b2b13a6300
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Joureny II
• Version Model Number: E0016495-2
• Catalog Number: E0016495-2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556751589 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121393

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

[00885556751589]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-20
• Device Publish Date: 2019-05-10

On-Brand Devices [Joureny II]

• 00885556739020: JII CR TRIAL INSERT SZ 7-8 9MM R
• 00885556739006: JII CR TRIAL INSERT SZ 3-4 9MM R
• 00885556751589: ANKLE CLAMP
• 00885556783399: TIBIAL BASEPLATE TRIAL SZ 8 LT W/ BOSS
• 00885556783382: TIBIAL BASEPLATE TRIAL SZ 7 LT W/ BOSS