VISIONAIRE LEGION V0100023

GUDID 03596010653147

VISIONAIRE RIGHT CUTTING BLOCK KIT - LEGION PRIMARY

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 03596010653147
• NIH Device Record Key: e870468c-6b28-430f-8777-397d17708512
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISIONAIRE LEGION
• Version Model Number: V0100023
• Catalog Number: V0100023
• 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: true
• 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
• 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	03596010653147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082358

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: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [VISIONAIRE LEGION]

• 00885556599501: NS VIS LGNP FP KIT F5 T4 PSHF RT
• 00885556599495: NS VIS LGNP FP KIT F5 T3 PSHF RT
• 00885556599303: NS VIS LGNP FP KIT F5 T4 PSHF LT
• 00885556599297: NS VIS LGNP FP KIT F5 T3 PSHF LT
• 00885556598818: NS VIS LGNP FP KIT F5 T4 CRHF RT
• 00885556598801: NS VIS LGNP FP KIT F5 T3 CRHF RT
• 00885556598641: NS VIS LGNP FP KIT F5 T4 CRHF LT
• 00885556598634: NS VIS LGNP FP KIT F5 T3 CRHF LT
• 00885556583074: NON STERILE VISIONAIRE RIGHT CUTTING BLOCK KIT - LEGION PRIM
• 00885556583067: NON STERILE VISIONAIRE LEFT CUTTING BLOCK KIT - LEGION PRIMA
• 00885556583050: NON STERILE VISIONAIRE PROXIMAL TIBIA CUTTING BLOCK - LEGION
• 00885556583043: NON STERILE VISIONAIRE DISTAL FEMUR CUTTING BLOCK - LEGION P
• 00885556581933: VIS LGNP FP KIT F6 T6 PSHF RT
• 00885556581926: VIS LGNP FP KIT F6 T5 PSHF RT
• 00885556581919: VIS LGNP FP KIT F6 T4 PSHF RT
• 00885556581902: VIS LGNP FP KIT F6 T3 PSHF RT
• 00885556581896: VIS LGNP FP KIT F5 T6 PSHF RT
• 00885556581889: VIS LGNP FP KIT F5 T5 PSHF RT
• 00885556581872: VIS LGNP FP KIT F4 T6 PSHF RT
• 00885556581865: VIS LGNP FP KIT F4 T5 PSHF RT
• 00885556581858: VIS LGNP FP KIT F4 T4 PSHF RT
• 00885556581841: VIS LGNP FP KIT F4 T3 PSHF RT
• 00885556581834: VIS LGNP FP KIT F6 T6 PSHF LT
• 00885556581827: VIS LGNP FP KIT F6 T5 PSHF LT
• 00885556581810: VIS LGNP FP KIT F6 T4 PSHF LT
• 00885556581803: VIS LGNP FP KIT F6 T3 PSHF LT
• 00885556581797: VIS LGNP FP KIT F5 T6 PSHF LT
• 00885556581780: VIS LGNP FP KIT F5 T5 PSHF LT
• 00885556581773: VIS LGNP FP KIT F4 T6 PSHF LT
• 00885556581766: VIS LGNP FP KIT F4 T5 PSHF LT
• 00885556581759: VIS LGNP FP KIT F4 T4 PSHF LT
• 00885556581742: VIS LGNP FP KIT F4 T3 PSHF LT
• 00885556581735: VIS LGNP FP KIT F6 T6 CRHF RT
• 00885556581728: VIS LGNP FP KIT F6 T5 CRHF RT
• 00885556581711: VIS LGNP FP KIT F6 T4 CRHF RT
• 00885556581704: VIS LGNP FP KIT F6 T3 CRHF RT
• 00885556581698: VIS LGNP FP KIT F5 T6 CRHF RT
• 00885556581681: VIS LGNP FP KIT F5 T5 CRHF RT
• 00885556581674: VIS LGNP FP KIT F4 T6 CRHF RT
• 00885556581667: VIS LGNP FP KIT F4 T5 CRHF RT
• 00885556581438: VIS LGNP FP KIT F6 T6 CRHF LT
• 00885556581308: VIS LGNP FP KIT F4 T4 CRHF RT
• 00885556581087: VIS LGNP FP KIT F4 T3 CRHF RT
• 00885556581070: VIS LGNP FP KIT F6 T5 CRHF LT
• 00885556580721: VIS LGNP FP KIT F6 T4 CRHF LT
• 00885556580714: VIS LGNP FP KIT F6 T3 CRHF LT
• 00885556580547: VIS LGNP FP KIT F5 T6 CRHF LT
• 00885556579237: VIS LGNP FP KIT F4 T6 CRHF LT
• 00885556579220: VIS LGNP FP KIT F5 T5 CRHF LT
• 00885556579190: VIS LGNP FP KIT F4 T5 CRHF LT