AccessGUDID - DEVICE: CollaFlex (D767C0703010)

GUDID

Device Identifier (DI) Information

Brand Name: CollaFlex
Version or Model: 30mm x 40mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C07-0301
Company Name: UNICARE BIOMEDICAL INC.

Primary DI Number: D767C0703010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038023573 *Terms of Use

Device Description: Resorbable COLLAFLEX® membranes are derived from porcine pericardium through careful purification and sterilization processes to avoid antigenic reactions. The non-cross-linked membranes retain the natural microfibril structure of the pericardium, providing excellent biocompatibility and extended barrier function for guided bone regeneration applications. COLLAFLEX® membranes are easily drapable and can be fixated with sutures and bone tacks.

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?
58709	Collagen dental regeneration membrane	A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery and applied to grafted bone defects in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPL	Barrier, Animal Source, Intraoral

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200623	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 1 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 and consult instructions for use.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 30mm x 40mm

Device Record Status

Public Device Record Key: 83ee71cb-c2eb-46a0-89e5-c056b8eed86b
Public Version Date: October 14, 2024
Public Version Number: 2
DI Record Publish Date: January 10, 2024