Yxoss

GUDID 04251880700009

ReOss GmbH

Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh Dental/maxillofacial surgical mesh

• Primary Device ID: 04251880700009
• NIH Device Record Key: a40e76d8-0113-4f50-8bca-20999152e02b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yxoss
• Version Model Number: Yxoss CBR
• Company DUNS: 341422829
• Company Name: ReOss GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251880700009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192747

FDA Product Code

• JEY: Plate, Bone

Sterilization

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

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

[04251880700009]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-05
• Device Publish Date: 2020-10-28