GII E0016359-12

GUDID 00885556740101

GII CR DEEP FLEX INSERT TRIAL 5-6 11MM

Smith & Nephew, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00885556740101
• NIH Device Record Key: 0784446a-31aa-49f4-a884-d7438c77eeec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GII
• Version Model Number: E0016359-12
• Catalog Number: E0016359-12
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556740101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121443

FDA Product Code

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

Sterilization

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

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

[00885556740101]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-25

On-Brand Devices [GII]

• 00885556741252: GII PS HIGH FLEX INSERT 7-8 12MM
• 00885556741245: GII PS HIGH FLEX INSERT 7-8 11MM
• 00885556741238: GII PS HIGH FLEX INSERT 7-8 10MM
• 00885556741221: GII PS HIGH FLEX INSERT 7-8 9MM
• 00885556741214: GII PS HIGH FLEX INSERT 5-6 12MM
• 00885556741207: GII PS HIGH FLEX INSERT 5-6 11MM
• 00885556741191: GII PS HIGH FLEX INSERT 5-6 10MM
• 00885556741184: GII PS HIGH FLEX INSERT 5-6 9MM
• 00885556741177: GII PS HIGH FLEX INSERT 3-4 12MM
• 00885556741160: GII PS HIGH FLEX INSERT 3-4 11MM
• 00885556741153: GII PS HIGH FLEX INSERT 3-4 10MM
• 00885556741146: GII PS HIGH FLEX INSERT 3-4 9MM
• 00885556741139: GII PS HIGH FLEX INSERT 1-2 12MM
• 00885556741122: GII PS HIGH FLEX INSERT 1-2 11MM
• 00885556741115: GII PS HIGH FLEX INSERT 1-2 10MM
• 00885556741108: GII PS HIGH FLEX INSERT 1-2 9MM
• 00885556740316: GII CONST. ARTICULAR INSERT 7-8 11MM
• 00885556740309: GII CONST. ARTICULAR INSERT 7-8 9MM
• 00885556740293: GII CONST. ARTICULAR INSERT 5-6 11MM
• 00885556740286: GII CONST. ARTICULAR INSERT 5-6 9MM
• 00885556740279: GII CONST. ARTICULAR INSERT 3-4 11MM
• 00885556740262: GII CONST. ARTICULAR INSERT 3-4 9MM
• 00885556740255: GII CONST. ARTICULAR INSERT 1-2 11MM
• 00885556740248: GII CONST. ARTICULAR INSERT 1-2 9MM
• 00885556740231: GII DISH ARTICULAR INSERT 7-8 11MM
• 00885556740224: GII DISH ARTICULAR INSERT 7-8 9MM
• 00885556740217: GII DISH ARTICULAR INSERT 5-6 11MM
• 00885556740200: GII DISH ARTICULAR INSERT 5-6 9MM
• 00885556740194: GII DISH ARTICULAR INSERT 3-4 11MM
• 00885556740187: GII DISH ARTICULAR INSERT 3-4 9MM
• 00885556740170: GII DISH ARTICULAR INSERT 1-2 11MM
• 00885556740163: GII DISH ARTICULAR INSERT 1-2 9MM
• 00885556740156: GII CR DEEP FLEX INSERT TRIAL 7-8 12MM
• 00885556740149: GII CR DEEP FLEX INSERT TRIAL 7-8 11MM
• 00885556740132: GII CR DEEP FLEX INSERT TRIAL 7-8 10MM
• 00885556740125: GII CR DEEP FLEX INSERT TRIAL 7-8 9MM
• 00885556740118: GII CR DEEP FLEX INSERT TRIAL 5-6 12MM
• 00885556740101: GII CR DEEP FLEX INSERT TRIAL 5-6 11MM
• 00885556740095: GII CR DEEP FLEX INSERT TRIAL 5-6 10MM
• 00885556740088: GII CR DEEP FLEX INSERT TRIAL 5-6 9MM
• 00885556740071: GII CR DEEP FLEX INSERT TRIAL 3-4 12MM
• 00885556740064: GII CR DEEP FLEX INSERT TRIAL 3-4 11MM
• 00885556740057: GII CR DEEP FLEX INSERT TRIAL 3-4 10MM
• 00885556740040: GII CR DEEP FLEX INSERT TRIAL 3-4 9MM
• 00885556740033: GII CR DEEP FLEX INSERT TRIAL 1-2 12MM
• 00885556740026: GII CR DEEP FLEX INSERT TRIAL 1-2 11MM
• 00885556740019: GII CR DEEP FLEX INSERT TRIAL 1-2 10MM
• 00885556740002: GII CR DEEP FLEX INSERT TRIAL 1-2 9MM
• 00885556739990: PITCHFORK HANDLE
• 00885556739983: GII CR FEMORAL IMPACTOR