Silicone Toe System FGT-50T

GUDID 00885556834435

FGT IMPLANT SIZE 50

Smith & Nephew, Inc.

Total metatarsophalangeal joint prosthesis, one-piece

• Primary Device ID: 00885556834435
• NIH Device Record Key: 36bdddfb-660f-43bf-897c-d149667f7d93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Toe System
• Version Model Number: FGT-50T
• Catalog Number: FGT-50T
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556834435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981194

FDA Product Code

• KWH: PROSTHESIS, TOE, CONSTRAINED, 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: 2
• Public Version Date: 2023-09-07
• Device Publish Date: 2022-12-22

On-Brand Devices [Silicone Toe System]

• 00885556834633: UNIVERSAL HANDLE
• 00885556834619: LID FOR LMP CASE
• 00885556834510: FGT SYSTEM PROXIMAL BROACH SMALL
• 00885556834503: FGT SYSTEM PROXIMAL BROACH LARGE
• 00885556834497: LID FOR FGT CASE
• 00885556834480: FGT IMPACTOR
• 00885556834473: FGT SYSTEM DISTAL BROACH SMALL
• 00885556834466: FGT SYSTEM DISTAL BROACH LARGE
• 00885556834459: FGT SYSTEM CUTTING GUIDE SMALL
• 00885556834442: FGT SYSTEM CUTTING GUIDE LARGE
• 00885556834350: CGT BROACH PROXIMAL ONE SIZE
• 00885556834343: LID FOR CGT CASE
• 00885556834336: CGT BROACH DISTAL ONE SIZE
• 00885556834220: BASE FOR LMP CASE
• 00885556834213: BASE FOR CGT CASE
• 00885556834190: BASE FOR FGT CASE
• 00885556834206: TRAY MAT 6.7X1.6
• 00885556834626: LMP SYSTEM PROXIMAL BROACH. ONE SIZE
• 00885556834602: LMP SYSTEM DISTAL BROACH. ONE SIZE
• 00885556834596: LMP IMPLANT SIZE 50
• 00885556834589: LMP SYSTEM IMPLANT TRIAL SIZER 50
• 00885556834572: LMP IMPLANT SIZE 40
• 00885556834565: LMP SYSTEM IMPLANT TRIAL SIZER 40
• 00885556834558: LMP IMPLANT SIZE 30
• 00885556834541: LMP SYSTEM IMPLANT TRIAL SIZER 30
• 00885556834534: LMP IMPLANT SIZE 20
• 00885556834527: LMP SYSTEM IMPLANT TRIAL SIZER 20
• 00885556834435: FGT IMPLANT SIZE 50
• 00885556834428: FGT SYSTEM IMPLANT TRIAL SIZER 50
• 00885556834411: FGT IMPLANT SIZE 40
• 00885556834404: FGT SYSTEM IMPLANT TRIAL SIZER 40
• 00885556834398: FGT IMPLANT SIZE 30
• 00885556834381: FGT SYSTEM IMPLANT TRIAL SIZER 30
• 00885556834374: FGT IMPLANT SIZE 20
• 00885556834367: FGT SYSTEM IMPLANT TRIAL SIZER 20
• 00885556834329: CGT IMPLANT SIZE 60
• 00885556834312: CGT SIZER SIZE 60
• 00885556834305: CGT IMPLANT SIZE 50
• 00885556834299: CGT SIZER SIZE 50
• 00885556834282: CGT IMPLANT SIZE 40
• 00885556834275: CGT SIZER SIZE 40
• 00885556834268: CGT IMPLANT SIZE 30
• 00885556834251: CGT SIZER SIZE 30
• 00885556834244: CGT IMPLANT SIZE 20
• 00885556834237: CGT SIZER SIZE 20