VISIONAIRE LEGION V0300421

GUDID 00885556581759

VIS LGNP FP KIT F4 T4 PSHF LT

Smith & Nephew, Inc.

Total knee prosthesis implantation guide-instrument kit

• Primary Device ID: 00885556581759
• NIH Device Record Key: e52f4b80-e76c-41a9-8af1-30429bd4cb28
• Commercial Distribution Discontinuation: 2017-10-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VISIONAIRE LEGION
• Version Model Number: V0300421
• Catalog Number: V0300421
• 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)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	00885556581759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143226

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-02

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