GENESIS 71204669

GUDID 03596010184764

GENESIS C/R ARTICULAR INSERT MED. RT. 25MM

Smith & Nephew, Inc.

Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 03596010184764
• NIH Device Record Key: d314a05b-44df-4ab1-be47-60deffc3f046
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENESIS
• Version Model Number: 71204669
• Catalog Number: 71204669
• 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)821-5700
• 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	03596010184764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952271

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: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-25

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