MetaFix™ Ludloff Locking Plate FH02138

GUDID 04048266076298

TiAl6V4 ELI non-sterile

Merete GmbH

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 04048266076298
• NIH Device Record Key: 673a9229-22ab-4db2-ba4e-7e02ce9366ae
• Commercial Distribution Discontinuation: 2022-01-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MetaFix™ Ludloff Locking Plate
• Version Model Number: left 38
• Catalog Number: FH02138
• 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: 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: 630-613-7182
• Email: service@merete.medical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048266076298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090063

FDA Product Code

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

Sterilization

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

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

[04048266076298]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-01-11
• Device Publish Date: 2015-10-15

On-Brand Devices [MetaFix™ Ludloff Locking Plate]

• 04048266076298: TiAl6V4 ELI non-sterile
• 04048266076281: TiAl6V4 ELI non-sterile
• 04048266076274: TiAl6V4 ELI non-sterile
• 04048266076229: TiAl6V4 ELI non-sterile
• 04048266076212: TiAl6V4 ELI non-sterile
• 04048266076205: TiAl6V4 ELI non-sterile