Cytoflex Mesh

Basic Information

• Brand Name: Cytoflex Mesh
• Primary DI: D767C0244010
• Version / Model: M4-400
• Catalog Number: C02-4401
• Company Name: UNICARE BIOMEDICAL INC.
• Labeler DUNS: 038023573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-23
• Public Version: 4
• Public Version Date: 2021-07-27
• Public Version Status: Update
• Public Device Record Key: 4e2396a8-4153-45c3-868f-35d0499c30f9

Device Description

Cytoflex® Mesh is made of pure implantable Titanium with a precision mesh profile. This product is designed for use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate bone augmentation through adequate fixation of the augmentation material. The thin, supple mesh conforms easily to tissue contours, and yet presents sufficient stiffness to maintain space over the bony defect.

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
48004	Dental bone matrix implant, metallic	A sterile non-bioabsorbable device made of metal and/or metal oxide [e.g., titanium (Ti)] implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically available as porous granules.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D767C0244010	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K021511	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 65 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry, well ventilated environment. Keep out of sunlight.