CollaFlex C07-0201

GUDID D767C0702010

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.

UNICARE BIOMEDICAL INC.

Collagen dental regeneration membrane
Primary Device IDD767C0702010
NIH Device Record Keyee68371c-d3ca-435f-81e7-e0deafeb6f64
Commercial Distribution StatusIn Commercial Distribution
Brand NameCollaFlex
Version Model Number20mm x 30mm
Catalog NumberC07-0201
Company DUNS038023573
Company NameUNICARE BIOMEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com
Phone949-305-9600
Emailsales@unicarebiomedical.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD767C0702010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPLBarrier, Animal Source, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-10-14
Device Publish Date2024-01-10

On-Brand Devices [CollaFlex]

D767C0703010Resorbable COLLAFLEX® membranes are derived from porcine pericardium through careful purificati
D767C0702010Resorbable COLLAFLEX® membranes are derived from porcine pericardium through careful purificati
D767C0701010Resorbable COLLAFLEX® membranes are derived from porcine pericardium through careful purificati

Trademark Results [CollaFlex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COLLAFLEX
COLLAFLEX
90296975 not registered Live/Pending
Collaflex
2020-11-03
COLLAFLEX
COLLAFLEX
77325623 not registered Dead/Abandoned
C. R. Bard, Inc.
2007-11-09

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