JII E0016339-8

GUDID 00885556738481

JII BCS TRIAL INSERT 3-4 12MM R

Smith & Nephew, Inc.

Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 00885556738481
• NIH Device Record Key: 831be7ca-530e-4152-ab35-f6a6d3d9eb62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JII
• Version Model Number: E0016339-8
• Catalog Number: E0016339-8
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556738481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111711

FDA Product Code

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

Sterilization

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

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

[00885556738481]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-02-01

On-Brand Devices [JII]

• 00885556741597: IM TIBIAL STYLUS ASSEMBLY
• 00885556740422: IM ROD SHORT
• 00885556740415: IM ROD LONG
• 00885556740408: SEVEN DEGREE VALGUS COLLET
• 00885556740392: SIX DEGREE VALGUS COLLET
• 00885556740385: FIVE DEGREE VALGUS COLLET
• 00885556740378: FOUR DEGREE VALGUS COLLET
• 00885556740361: ADJUSTABLE VALGUS GUIDE
• 00885556740354: FIXED VALGUS GUIDE
• 00885556740347: FIXED VALGUS BRIDGE
• 00885556740330: DISTAL FEMORAL CUTTING BLOCK
• 00885556738566: JII BCS TRIAL INSERT 7-8 12MM R
• 00885556738559: JII BCS TRIAL INSERT 7-8 11MM R
• 00885556738542: JII BCS TRIAL INSERT 7-8 10MM R
• 00885556738535: JII BCS TRIAL INSERT 7-8 9MM R
• 00885556738528: JII BCS TRIAL INSERT 5-6 12MM R
• 00885556738511: JII BCS TRIAL INSERT 5-6 11MM R
• 00885556738504: JII BCS TRIAL INSERT 5-6 10MM R
• 00885556738498: JII BCS TRIAL INSERT 5-6 9MM R
• 00885556738481: JII BCS TRIAL INSERT 3-4 12MM R
• 00885556738474: JII BCS TRIAL INSERT 3-4 11MM R
• 00885556738467: JII BCS TRIAL INSERT 3-4 10MM R
• 00885556738450: JII BCS TRIAL INSERT 3-4 9MM R
• 00885556738443: JII BCS TRIAL INSERT 1-2 12MM R
• 00885556738436: JII BCS TRIAL INSERT 1-2 11MM R
• 00885556738429: JII BCS TRIAL INSERT 1-2 10MM R
• 00885556738412: JII BCS TRIAL INSERT SZ 1-2 9MM R
• 00885556738405: PITCHFORK HANDLE FOR TRIAL INSERTS
• 00885556738399: JII BCS TRIAL INSERT 7-8 12MM L
• 00885556738382: JII BCS TRIAL INSERT 7-8 11MM L
• 00885556738368: JII BCS TRIAL INSERT 7-8 10MM L
• 00885556738344: JII BCS TRIAL INSERT 7-8 9MM L
• 00885556738320: JII BCS TRIAL INSERT 5-6 12MM L
• 00885556738306: JII BCS TRIAL INSERT 5-6 11MM L
• 00885556738290: JII BCS TRIAL INSERT 5-6 10MM L
• 00885556738276: JII BCS TRIAL INSERT 5-6 9MM L
• 00885556738269: JII BCS TRIAL INSERT 3-4 12MM L
• 00885556738245: JII BCS TRIAL INSERT 3-4 11MM L
• 00885556738221: JII BCS TRIAL INSERT 3-4 10MM L
• 00885556738214: JII BCS TRIAL INSERT 3-4 9MM L
• 00885556738191: JII BCS TRIAL INSERT SZ 1-2 12MM L
• 00885556738184: JII BCS TRIAL INSERT SZ 1-2 11MM L
• 00885556738177: JII BCS TRIAL INSERT SZ 1-2 10MM L
• 00885556738160: JII BCS TRIAL INSERT SZ 1-2 9MM L
• 00885556738092: JII DD TRIAL INSERT 7-8 12MM R
• 00885556738085: JII DD TRIAL INSERT 7-8 11MM R
• 00885556738078: JII DD TRIAL INSERT 7-8 10MM R
• 00885556738061: JII DD TRIAL INSERT 7-8 9MM R
• 00885556738054: JII DD TRIAL INSERT 5-6 12MM R
• 00885556738047: JII DD TRIAL INSERT 5-6 11MM R