VISIONAIRE FASTPAK 71442205

GUDID 00885556648025

LEGION FP TIBIA TRIAL SZ 5 LT

Smith & Nephew, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00885556648025
• NIH Device Record Key: 2ef0fdfd-236e-4000-b4ff-f1fede63fd94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISIONAIRE FASTPAK
• Version Model Number: 71442205
• Catalog Number: 71442205
• 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)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
• 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	00885556648025 [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: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-03-30

On-Brand Devices [VISIONAIRE FASTPAK]

• 00885556648315: LEGION FP ISRT TRL SZ 7-8 CRDD
• 00885556648308: LEGION FP ISRT TRL SZ 5-6 CRDD
• 00885556648292: LEGION FP ISRT TRL SZ 3-4 CRDD
• 00885556648285: LEGION FP ISRT TRL SZ 7-8 PSHF
• 00885556648278: LEGION FP ISRT TRL SZ 5-6 PSHF
• 00885556648261: LEGION FP ISRT TRL SZ 3-4 PSHF
• 00885556648254: LEGION FP ISRT TRL SZ 7-8 CRHF
• 00885556648247: LEGION FP ISRT TRL SZ 5-6 CRHF
• 00885556648230: LEGION FP ISRT TRL SZ 3-4 CRHF
• 00885556648223: LEGION FP FIN PUNCH SZ 7-8
• 00885556648216: LEGION FP FIN PUNCH SZ 5-6
• 00885556648209: LEGION FP FIN PUNCH SZ 3-4
• 00885556648193: LEGION FP FEMORAL TRIAL SZ 7 RT
• 00885556648186: LEGION FP FEMORAL TRIAL SZ 6 RT
• 00885556648179: LEGION FP FEMORAL TRIAL SZ 5 RT
• 00885556648162: LEGION FP FEMORAL TRIAL SZ 4 RT
• 00885556648155: LEGION FP FEMORAL TRIAL SZ 3 RT
• 00885556648148: LEGION FP FEMORAL TRIAL SZ 7 LT
• 00885556648131: LEGION FP FEMORAL TRIAL SZ 6 LT
• 00885556648124: LEGION FP FEMORAL TRIAL SZ 5 LT
• 00885556648117: LEGION FP FEMORAL TRIAL SZ 4 LT
• 00885556648100: LEGION FP FEMORAL TRIAL SZ 3 LT
• 00885556648094: LEGION FP TIBIA TRIAL SZ 7 RT
• 00885556648087: LEGION FP TIBIA TRIAL SZ 6 RT
• 00885556648070: LEGION FP TIBIA TRIAL SZ 5 RT
• 00885556648063: LEGION FP TIBIA TRIAL SZ 4 RT
• 00885556648056: LEGION FP TIBIA TRIAL SZ 3 RT
• 00885556648049: LEGION FP TIBIA TRIAL SZ 7 LT
• 00885556648032: LEGION FP TIBIA TRIAL SZ 6 LT
• 00885556648025: LEGION FP TIBIA TRIAL SZ 5 LT
• 00885556648018: LEGION FP TIBIA TRIAL SZ 4 LT
• 00885556648001: LEGION FP TIBIA TRIAL SZ 3 LT