Cytoplast™ Osteo-Mesh TM-300

Basic Information

• Brand Name: Cytoplast™ Osteo-Mesh TM-300
• Primary DI: D765TM4545NS0
• Version / Model: TM4545NS
• Company Name: Osteogenics Biomedical Inc
• Labeler DUNS: 123853058
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-03
• Public Version: 5
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 680b0de8-be46-49c2-8812-b9f1cf31bc55

Device Description

Titanium Ridge Augmentation Mesh, 45 mm x 45 mm, Non-sterile

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 Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
46580	Extra-gynaecological surgical mesh, metal	A non-bioabsorbable, implantable material (e.g., flat sheet) made from made from a biocompatible metal, with appropriate mechanical characteristics for implantation, intended for an extra-gynaecological tissue repair/reinforcement application(s) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction); it is not primarily intended for dental use. Disposable devices associated with implantation may be supplied with the mesh.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D765TM4545NS0	HIBCC

Device Sizes

Type	Value	Unit	Text
Length	45	Millimeter
Width	45	Millimeter