Yxoss

Basic Information

• Brand Name: Yxoss
• Primary DI: 04251880700009
• Version / Model: Yxoss CBR
• Company Name: ReOss GmbH
• Labeler DUNS: 341422829
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-28
• Public Version: 1
• Public Version Date: 2020-11-05
• Public Version Status: New
• Public Device Record Key: a40e76d8-0113-4f50-8bca-20999152e02b

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JEY	Plate, Bone	Dental	872.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63439	Dental/maxillofacial surgical mesh	An implantable, non-bioabsorbable, woven/knitted porous material made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE)] intended to temporarily provide stabilization and support to a bone graft in the alveolar ridges, maxilla, or mandible. It is typically placed between the bone graft and soft tissue during dental or maxillofacial reconstruction and augmentation surgical procedures.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251880700009	GS1

Premarket Submissions

Submission Number	Supplement Number
K192747	000