GENESIS 71204749

GUDID 03596010185099

GENESIS P/S ARTICULAR INSERT MED. RIGHT 15MM

Smith & Nephew, Inc.

Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 03596010185099
• NIH Device Record Key: 82c55bb1-5ffd-4a46-92c6-f2d205b5ad64
• Commercial Distribution Discontinuation: 2016-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GENESIS
• Version Model Number: 71204749
• Catalog Number: 71204749
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010185099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K946088

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-09-28

On-Brand Devices [GENESIS]

• 00885556616680: GENESIS II HI FLEX PS INSERT SIZE 3-4 NYLON 12 20MM TRIAL
• 00885556616673: GENESIS II HI FLEX PS INSERT SIZE 3-4 UHMWPE 20MM
• 00885556057315: GENESIS UNI SYMMETRIC ALL-POLY TIBIA 42 X 7MM
• 00885556057063: GENESIS UNI SYMMETRIC ALL-POLY TIBIA 34X 7MM
• 00885556056677: GENESIS UNI SYMMETRIC ALL-POLY TIBIA 31X 7MM
• 00885556056479: GENESIS UNI SYMMETRIC ALL-POLY TIBIA 29 X 7MM
• 00885556055649: GENESIS UNI SYMMETRIC ALL-POLY TIBIA 38X 7MM
• 00885556055564: GNS TROCAR PIN 1/8 X 4 IN
• 00885556046494: GENESIS II NON SLOTTED A/P CUTTING BLOCK SZ 2
• 03596010185723: GENESIS 1/8 PIN DRIVER
• 03596010185716: GENESIS 1/8 INCH PIN PULLER
• 03596010514103: GENESIS UNI ARTICULAR INSERT MEDIUM/LARGE 8MM
• 03596010500779: GENESIS UNI ARTICULAR INSERT XLARGE-MAGNUM 12 MM
• 03596010500762: GENESIS UNI ARTICULAR INSERT XL-MG 11 MM
• 03596010500748: GENESIS UNI ARTICULAR INSERT XLARGE-MAGNUM 9 MM
• 03596010500724: GENESIS UNI ARTICULAR INSERT MD-LG 12 MM
• 03596010500694: GENESIS UNI ARTICULAR INSERT MEDIUM-LARGE 9 MM
• 03596010500687: GENESIS UNI ARTICULAR INSERT XSMALL-SMALL 12 MM
• 03596010500670: GENESIS UNI ARTICULAR INSERT XSMALL-SMALL 11 MM
• 03596010500649: GENESIS UNI ARTICULAR INSERT XSMALL-SMALL 8 MM
• 03596010185297: GENESIS P/S ARTICULAR INSERT X-LARGE LEFT 15MM
• 03596010185280: GENESIS P/S ARTICULAR INSERT X-LARGE LEFT 12MM
• 03596010185273: GENESIS P/S ARTICULAR INSERT X-LARGE LEFT 10MM
• 03596010185266: GENESIS P/S ARTICULAR INSERT X-LARGE LEFT 8MM
• 03596010185259: GENESIS P/S ARTICULAR INSERT X-LARGE RIGHT 15MM
• 03596010185242: GENESIS P/S ARTICULAR INSERT X-LARGE RIGHT 12MM
• 03596010185235: GENESIS P/S ARTICULAR INSERT X-LARGE RIGHT 10MM
• 03596010185228: GENESIS P/S ARTICULAR INSERT X-LARGE RIGHT 8MM
• 03596010185211: GENESIS P/S ARTICULAR INSERT LARGE LEFT 15MM
• 03596010185204: GENESIS P/S ARTICULAR INSERT LARGE LEFT 12MM
• 03596010185198: GENESIS P/S ARTICULAR INSERT LARGE LEFT 10MM
• 03596010185181: GENESIS P/S ARTICULAR INSERT LARGE LEFT 8MM
• 03596010185174: GENESIS P/S ARTICULAR INSERT LARGE RIGHT 15MM
• 03596010185167: GENESIS P/S ARTICULAR INSERT LARGE RIGHT 12MM
• 03596010185150: GENESIS P/S ARTICULAR INSERT LARGE RT. 10MM
• 03596010185143: GENESIS P/S ARTICULAR INSERT LARGE RT. 8MM
• 03596010185136: GENESIS P/S ARTICULAR INSERT MED. LEFT 15MM
• 03596010185129: GENESIS P/S ARTICULAR INSERT MED. LEFT 12MM
• 03596010185112: GENESIS P/S ARTICULAR INSERT MED. LEFT 10MM
• 03596010185105: GENESIS P/S ARTICULAR INSERT MED. LEFT 8MM
• 03596010185099: GENESIS P/S ARTICULAR INSERT MED. RIGHT 15MM
• 03596010185082: GENESIS P/S ARTICULAR INSERT MED. RIGHT 12MM
• 03596010185075: GENESIS P/S ARTICULAR INSERT MED. RIGHT 10MM
• 03596010185068: GENESIS P/S ARTICULAR INSERT MED. RIGHT 8MM
• 03596010185051: GENESIS P/S ARTICULAR INSERT SMALL LEFT 15MM
• 03596010185044: GENESIS P/S ARTICULAR INSERT SMALL LEFT 12MM
• 03596010185037: GENESIS P/S ARTICULAR INSERT SMALL LEFT 10MM
• 03596010185020: GENESIS P/S ARTICULAR INSERT SMALL LEFT 8MM
• 03596010185013: GENESIS P/S ARTICULAR INSERT SMALL RT. 15MM
• 03596010185006: GENESIS P/S ARTICULAR INSERT SMALL RT. 12MM