AccessGUDID - DEVICE: Perforated Cytoflex Ti-enforced (D767C0641010)

GUDID

Device Identifier (DI) Information

Brand Name: Perforated Cytoflex Ti-enforced
Version or Model: 32x40mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C06-4101
Company Name: UNICARE BIOMEDICAL INC.

Primary DI Number: D767C0641010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038023573 *Terms of Use

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

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 packaged is damaged.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd18ed15-3bf9-416f-b878-09795c81c01d
Public Version Date: July 22, 2024
Public Version Number: 1
DI Record Publish Date: July 12, 2024