ENGAGE 1-50040-003

GUDID 00885556874240

TIBIAL TRAY TRIAL SIZE 3 LEFT MEDIAL

Smith & Nephew, Inc.

Joint prosthesis implantation kit, reusable

• Primary Device ID: 00885556874240
• NIH Device Record Key: 68536083-21cf-40fa-80e3-070b62180df5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENGAGE
• Version Model Number: 1-50040-003
• Catalog Number: 1-50040-003
• 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	00885556874240 [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

[00885556874240]

Moist Heat or Steam Sterilization

[00885556874240]

Moist Heat or Steam Sterilization

[00885556874240]

Moist Heat or Steam Sterilization

[00885556874240]

Moist Heat or Steam Sterilization

[00885556874240]

Moist Heat or Steam Sterilization

[00885556874240]

Moist Heat or Steam Sterilization

[00885556874240]

Moist Heat or Steam Sterilization

[00885556874240]

Moist Heat or Steam Sterilization

[00885556874240]

Moist Heat or Steam Sterilization

[00885556874240]

Moist Heat or Steam Sterilization

[00885556874240]

Moist Heat or Steam Sterilization

[00885556874240]

Moist Heat or Steam Sterilization

[00885556874240]

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: 2023-01-11

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