Synthacer 6.2G03

GUDID 04250971400613

Synthacer® 600 granules, HA, particle size 2.6 - 4.8 mm, 20 ml

medArtis Medizinprodukte und Forschung Aktiengesellschaft

Bone matrix implant, synthetic

• Primary Device ID: 04250971400613
• NIH Device Record Key: 67be45d6-7674-48f7-aa90-cd5b9cc2f4db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synthacer
• Version Model Number: T62G03-20-1
• Catalog Number: 6.2G03
• Company DUNS: 313163545
• Company Name: medArtis Medizinprodukte und Forschung Aktiengesellschaft
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Pore Size: 600 Micrometer
• Total Volume: 20 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250971400613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041177

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

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• 04250971403959: Synthacer® 1000 rounded granules Ceround®, "negative", HA, particle size 2.6 - 4.8 mm
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