Movement Great Toe System PIS-890-00

GUDID 00885556828359

PROXIMAL PHAL IMPLANT SIZER

Smith & Nephew, Inc.

Surgical implant template, reusable

• Primary Device ID: 00885556828359
• NIH Device Record Key: c4eb3864-7dd2-4698-927a-c564db7390da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Movement Great Toe System
• Version Model Number: PIS-890-00
• Catalog Number: PIS-890-00
• 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: 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	00885556828359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092047

FDA Product Code

• KWD: PROSTHESIS, TOE, HEMI-, PHALANGEAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

Moist Heat or Steam Sterilization

[00885556828359]

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: 2022-12-21

On-Brand Devices [Movement Great Toe System]

• 00885556828380: PROXIMAL PHALANX SURFACE REAMER SZ. 30/40
• 00885556828373: PROXIMAL PHALANX SURFACE REAMER SZ. 10/20
• 00885556828342: METATARSAL SURFACE REAMER SZ. 30/40
• 00885556828335: METATARSAL SURFACE REAMER SZ. 10/20
• 00885556828366: PROXIMAL PHALANX BROACH
• 00885556828199: PROXIMAL PHALANX IMPACTOR
• 00885556828182: METATARSAL IMPACTOR
• 00885556828168: 4.5MM CANUULATED DRIL
• 00885556828151: METATARSAL DORSAL CUT GUIDE
• 00885556828113: SIZER ALIGMENT GUIDE
• 00885556828502: PROXIMAL PHALANX TOTAL TRIAL SZ. 40
• 00885556828496: PROXIMAL PHALANX HEMI TRIAL SZ. 40
• 00885556828489: METATARSAL TRIAL SZ. 40
• 00885556828472: PROXIMAL PHALANX TOTAL TRIAL SZ. 30
• 00885556828465: PROXIMAL PHALANX HEMI TRIAL SZ. 30
• 00885556828458: METATARSAL TRIAL SZ. 30
• 00885556828441: PROXIMAL PHALANX TOTAL TRIAL SZ. 20
• 00885556828434: PROXIMAL PHALANX HEMI TRIAL SZ. 20
• 00885556828427: METATARSAL TRIAL SZ. 20
• 00885556828410: PROXIMAL PHALANX TOTAL TRIAL SZ. 10
• 00885556828403: PROXIMAL PHALANX HEMI TRIAL SZ. 10
• 00885556828397: METATARSAL TRIAL SZ. 10
• 00885556828359: PROXIMAL PHAL IMPLANT SIZER
• 00885556828328: METATARSAL SIZER
• 00885556828311: MGT MOVEMENT PROX. PHAL. TOTAL SZ. 40
• 00885556828304: MGT MOVEMENT PROX. PHALANX HEMI SZ. 40
• 00885556828298: MGT MOVEMENT METATARSAL SZ. 40
• 00885556828281: MGT MOVEMENT PROX. PHAL. TOTAL SZ. 30
• 00885556828274: MGT MOVEMENT PROX. PHALANX HEMI SZ. 30
• 00885556828267: MGT MOVEMENT METATARSAL SZ. 30
• 00885556828250: MGT MOVEMENT PROX. PHAL. TOTAL SZ. 20
• 00885556828243: MGT MOVEMENT PROX. PHALANX HEMI SZ. 20
• 00885556828236: MGT MOVEMENT METATARSAL SZ. 20
• 00885556828229: MGT MOVEMENT PROX. PHAL. TOTAL SZ. 10
• 00885556828212: MGT MOVEMENT PROX. PHALANX HEMI SZ. 10
• 00885556828205: MGT MOVEMENT METATARSAL SZ. 10
• 00885556828175: 2.0MM X 125MM GUIDE PIN
• 00885556828144: MGT TRIAL CADDY LID (GREEN)
• 00885556828137: MGT TRIAL CADDY
• 00885556828120: MGT BASE (CASE)