ToeMobile™ Great Toe Endoprosthesis FM20000

GUDID 04048266000958

CoCr sterile

Merete GmbH

Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis

• Primary Device ID: 04048266000958
• NIH Device Record Key: 13516a17-014d-44d9-88ba-3b7a2fdb55e1
• Commercial Distribution Discontinuation: 2020-11-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ToeMobile™ Great Toe Endoprosthesis
• Version Model Number: Metatarsal 0
• Catalog Number: FM20000
• Company DUNS: 313267265
• Company Name: Merete GmbH
• 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: true
• 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: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04048266000958 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072251

FDA Product Code

• LZJ: Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-02-21
• Device Publish Date: 2015-10-15

On-Brand Devices [ToeMobile™ Great Toe Endoprosthesis]

• 04048266000972: CoCr sterile
• 04048266000965: CoCr sterile
• 04048266000958: CoCr sterile
• 04048266000941: CoCr sterile