ENGAGE 1-51058-000

GUDID 00885556875940

FEMORAL SIZER LEFT MEDIAL

Smith & Nephew, Inc.

Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable

• Primary Device ID: 00885556875940
• NIH Device Record Key: b78f8af8-eda2-479f-bcad-5961877e0051
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENGAGE
• Version Model Number: 1-51058-000
• Catalog Number: 1-51058-000
• Company DUNS: 045483575
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556875940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190439

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00885556875940]

Moist Heat or Steam Sterilization

[00885556875940]

Moist Heat or Steam Sterilization

[00885556875940]

Moist Heat or Steam Sterilization

[00885556875940]

Moist Heat or Steam Sterilization

[00885556875940]

Moist Heat or Steam Sterilization

[00885556875940]

Moist Heat or Steam Sterilization

[00885556875940]

Moist Heat or Steam Sterilization

[00885556875940]

Moist Heat or Steam Sterilization

[00885556875940]

Moist Heat or Steam Sterilization

[00885556875940]

Moist Heat or Steam Sterilization

[00885556875940]

Moist Heat or Steam Sterilization

[00885556875940]

Moist Heat or Steam Sterilization

[00885556875940]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-07
• Device Publish Date: 2023-01-13

On-Brand Devices [ENGAGE]

• 00885556873014: POROUS COATED FEMORAL COMP, SIZE 5-LEFT MEDIAL
• 00885556873007: POROUS COATED FEMORAL COMP, SIZE 5-RIGHT MEDIAL
• 00885556872994: POROUS COATED FEMORAL COMP, SIZE 4-LEFT MEDIAL
• 00885556872987: POROUS COATED FEMORAL COMP, SIZE 4-RIGHT MEDIAL
• 00885556872970: POROUS COATED FEMORAL COMP, SIZE 3-LEFT MEDIAL
• 00885556872963: POROUS COATED FEMORAL COMP, SIZE 3-RIGHT MEDIAL
• 00885556872956: POROUS COATED FEMORAL COMP, SIZE 2-LEFT MEDIAL
• 00885556872949: POROUS COATED FEMORAL COMP, SIZE 2-RIGHT MEDIAL
• 00885556872932: POROUS FEMORAL COMP, SIZE 1-LEFT MEDIAL
• 00885556872925: POROUS FEMORAL COMP, SIZE 1-RIGHT MEDIAL
• 00885556874202: TIBIAL DRILL
• 00885556874196: ENGAGE TIBIAL INSERT SIZE 6-RIGHT MED 9MM
• 00885556874189: TIBIAL AP SIZING WAND
• 00885556874172: TIBIAL SIZER SIZE 6 RIGHT MEDIAL
• 00885556874165: TIBIAL SIZER SIZE 5 RIGHT MEDIAL
• 00885556874158: TIBIAL SIZER SIZE 4 RIGHT MEDIAL
• 00885556874141: TIBIAL SIZER SIZE 3 RIGHT MEDIAL
• 00885556874134: ENGAGE TIBIAL INSERT SIZE 6-LEFT MED 13MM
• 00885556874127: TIBIAL SIZER SIZE 2 RIGHT MEDIAL
• 00885556874110: TIBIAL SIZER SIZE 1 RIGHT MEDIAL
• 00885556874103: TIBIAL SIZER SIZE 6 LEFT MEDIAL
• 00885556874097: ENGAGE TIBIAL INSERT SIZE 6-LEFT MED 11MM
• 00885556874080: TIBIAL SIZER SIZE 5 LEFT MEDIAL
• 00885556874073: TIBIAL SIZER SIZE 4 LEFT MEDIAL
• 00885556874066: TIBIAL SIZER SIZE 3 LEFT MEDIAL
• 00885556874059: ENGAGE TIBIAL INSERT SIZE 6-LEFT MED 10MM
• 00885556874042: TIBIAL SIZER SIZE 2 LEFT MEDIAL
• 00885556874035: TIBIAL SIZER SIZE 1 LEFT MEDIAL
• 00885556874028: ENGAGE TIBIAL INSERT SIZE 6-LEFT MED 9MM
• 00885556873984: ENGAGE TIBIAL INSERT SIZE 5-RIGHT MED 13MM
• 00885556873960: TIBIAL CENTERLINE GUIDE SIZE 5/6
• 00885556873953: TIBIAL CENTERLINE GUIDE SIZE 3/4
• 00885556873946: TIBIAL CENTERLINE GUIDE SIZE 1/2
• 00885556873939: ENGAGE TIBIAL INSERT SIZE 5-RIGHT MED 11MM
• 00885556873892: ENGAGE TIBIAL INSERT SIZE 5-RIGHT MED 10MM
• 00885556873854: ENGAGE TIBIAL INSERT SIZE 5-RIGHT MED 9MM
• 00885556873816: ENGAGE TIBIAL INSERT SIZE 5-LEFT MED 13MM
• 00885556873762: ENGAGE TIBIAL INSERT SIZE 5-LEFT MED 11MM
• 00885556873717: ENGAGE TIBIAL INSERT SIZE 5-LEFT MED 10MM
• 00885556873670: ENGAGE TIBIAL INSERT SIZE 5-LEFT MED 9MM
• 00885556873649: ENGAGE TIBIAL INSERT SIZE 4-RIGHT MED 13MM
• 00885556873601: ENGAGE TIBIAL INSERT SIZE 4-RIGHT MED 11MM
• 00885556873564: ENGAGE TIBIAL INSERT SIZE 4-RIGHT MED 10MM
• 00885556873526: ENGAGE TIBIAL INSERT SIZE 4-RIGHT MED 9MM
• 00885556873519: ENGAGE TIBIAL INSERT SIZE 4-LEFT MED 13MM
• 00885556873502: ENGAGE TIBIAL INSERT SIZE 4-LEFT MED 11MM
• 00885556873489: ENGAGE TIBIAL INSERT SIZE 4-LEFT MED 10MM
• 00885556873472: ENGAGE TIBIAL INSERT SIZE 4-LEFT MED 9MM
• 00885556873465: ENGAGE TIBIAL INSERT SIZE 3-RIGHT MED 13MM
• 00885556873458: ENGAGE TIBIAL INSERT SIZE 3-RIGHT MED 11MM