ToeMobile™ Phalangeal Implant FM12100

GUDID 04048266047250

TiAl6V4 ELI UHMWPE sterile

Merete GmbH

Partial metatarsophalangeal joint prosthesis

• Primary Device ID: 04048266047250
• NIH Device Record Key: 77e01548-9adc-4cb5-8910-fb672fba02ed
• Commercial Distribution Discontinuation: 2020-11-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ToeMobile™ Phalangeal Implant
• Version Model Number: 1.1
• Catalog Number: FM12100
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04048266047250 [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™ Phalangeal Implant]

• 04048266047304: TiAl6V4 ELI UHMWPE sterile
• 04048266047298: TiAl6V4 ELI UHMWPE sterile
• 04048266047281: TiAl6V4 ELI UHMWPE sterile
• 04048266047274: TiAl6V4 ELI UHMWPE sterile
• 04048266047267: TiAl6V4 ELI UHMWPE sterile
• 04048266047250: TiAl6V4 ELI UHMWPE sterile
• 04048266047243: TiAl6V4 ELI UHMWPE sterile
• 04048266047236: TiAl6V4 ELI UHMWPE sterile
• 04048266047229: TiAl6V4 ELI UHMWPE sterile