Perforated Cytoflex Ti-enforced

Basic Information

• Brand Name: Perforated Cytoflex Ti-enforced
• Primary DI: D767C0609010
• Version / Model: 19x26mm
• Catalog Number: C06-0901
• Company Name: UNICARE BIOMEDICAL INC.
• Labeler DUNS: 038023573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-12
• Public Version: 1
• Public Version Date: 2024-07-22
• Public Version Status: New
• Public Device Record Key: 8eea044b-e906-4a3e-a3cf-982c2d31e560

Device Description

Perforated Ti-Enforced® membranes are made of the same materials and features as Cytoflex® Ti-Enforced® membranes with the exception of perforation. The perforated macro holes allow for direct vascularization across the membrane. Both the Ti-Enforced® and perforated Ti-Enforced® membranes are designed to achieve predictable outcomes for GBR procedures.

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: Yes
• 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
NPK	Barrier, Synthetic, Intraoral	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62481	Pliable-polymer dental regeneration membrane, non-bioabsorbable	A sterile non-bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a pliable synthetic polymer material that is held in place between soft tissue and bone [e.g., with ligatures, sutures, or pins (may be attached/included)] and applied during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. A plasticizer to soften the membrane may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D767C0609010	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151344	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight.
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if packaged is damaged.