J2 E0016329-4

GUDID 00885556737453

J2 DD TRIAL INSERT 5-6 9MM R

Smith & Nephew, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00885556737453
• NIH Device Record Key: b1a54c01-b6bc-4209-9b28-b7e34d4ed0d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J2
• Version Model Number: E0016329-4
• Catalog Number: E0016329-4
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556737453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113482

FDA Product Code

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

Sterilization

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

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

[00885556737453]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-11
• Device Publish Date: 2019-01-11

On-Brand Devices [J2]

• 00885556737538: J2 DD TRIAL INSERT 7-8 12MM R
• 00885556737521: J2 DD TRIAL INSERT 7-8 11MM R
• 00885556737514: J2 DD TRIAL INSERT 7-8 10MM R
• 00885556737507: J2 DD TRIAL INSERT 7-8 9MM R
• 00885556737491: J2 DD TRIAL INSERT 7-8 12MM L
• 00885556737484: J2 DD TRIAL INSERT 7-8 11MM L
• 00885556737477: J2 DD TRIAL INSERT 7-8 10MM L
• 00885556737460: J2 DD TRIAL INSERT 7-8 9MM L
• 00885556737453: J2 DD TRIAL INSERT 5-6 9MM R
• 00885556737446: J2 DD TRIAL INSERT 5-6 9MM L
• 00885556737439: J2 DD TRIAL INSERT 1-2 9MM R
• 00885556737422: J2 DD TRIAL INSERT 1-2 9MM L