AccessGUDID - DEVICE: Cytoflex Resorb (D767C0302010)

GUDID

Device Identifier (DI) Information

Brand Name: Cytoflex Resorb
Version or Model: 20x25mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C03-0201
Company Name: UNICARE BIOMEDICAL INC.

Primary DI Number: D767C0302010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038023573 *Terms of Use

Device Description: Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb membranes are designed to enhance the adhesion of host cells, and at the same time provide a favorable environment for neo-vascularization and repopulation of bone cells to regenerate osseous tissue. The flexible barrier membranes are easily adaptable to tissue contours, yet offer sufficient duration to protect the bony defect from the intrusion of bacteria and soft tissue. Composed of synthetic polylactide and polyglycolide copolymers, Cytoflex® Resorb barriers are resorbable and do not require a second retrieval procedure.

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?
58502	Pliable-polymer dental regeneration membrane, bioabsorbable, ligated	A sterile 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	true

FDA Product Code

[?]

Product Code	Product Code Name
NPK	Barrier, Synthetic, Intraoral

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090083	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
Storage Environment Humidity: between 0 and 65 Percent (%) Relative Humidity
Special Storage Condition, Specify: Store in a dry, well ventilated environment. Keep out of sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4ef69d60-26c2-4d10-a78a-15b949796aad
Public Version Date: July 27, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2015