AccessGUDID - DEVICE: Cytoflex Ti-enforced (D767C0505010)

GUDID

Device Identifier (DI) Information

Brand Name: Cytoflex Ti-enforced
Version or Model: 14x24mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C05-0501
Company Name: UNICARE BIOMEDICAL INC.

Primary DI Number: D767C0505010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038023573 *Terms of Use

Device Description: Ti-Enforced® ePTFE membranes are a multi-layer, non-resorbable membrane intended to be surgically placed under the muco-periosteum to aid in tissue regeneration in accordance with the guided tissue regeneration principle. It is a barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NPK	Barrier, Synthetic, Intraoral

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151344	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep dry.
Special Storage Condition, Specify: Keep away from sunlight.
Special Storage Condition, Specify: Do not use if package is damaged.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 14x24mm

Device Record Status

Public Device Record Key: 3d16ebf1-f4c8-4971-9179-de397320c434
Public Version Date: January 18, 2024
Public Version Number: 1
DI Record Publish Date: January 10, 2024