MetaCun™ II Plate FH03035

GUDID 04048266167507

Merete GmbH

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 04048266167507
• NIH Device Record Key: d83e92c2-f885-4c15-baef-05147dfc9dcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MetaCun™ II Plate
• Version Model Number: 35
• Catalog Number: FH03035
• 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: 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(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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04048266167507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102688

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

[04048266167507]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-05-08
• Device Publish Date: 2018-08-14

On-Brand Devices [MetaCun™ II Plate]

• 04048266167460: MetaCun™ II Plate with Compression-Hole Size 33 TiAl6V4 ELI sterile
• 04048266167446: MetaCun™ II Plate with Compression-Hole Size 29 TiAl6V4 ELI sterile
• 04048266167507: 35
• 04048266167453: 31