Primary Device ID | D767C0702010 |
NIH Device Record Key | ee68371c-d3ca-435f-81e7-e0deafeb6f64 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CollaFlex |
Version Model Number | 20mm x 30mm |
Catalog Number | C07-0201 |
Company DUNS | 038023573 |
Company Name | UNICARE BIOMEDICAL INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com | |
Phone | 949-305-9600 |
sales@unicarebiomedical.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. |
Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use. |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D767C0702010 [Primary] |
NPL | Barrier, Animal Source, Intraoral |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-10-14 |
Device Publish Date | 2024-01-10 |
D767C0703010 | Resorbable COLLAFLEX® membranes are derived from porcine pericardium through careful purificati |
D767C0702010 | Resorbable COLLAFLEX® membranes are derived from porcine pericardium through careful purificati |
D767C0701010 | Resorbable COLLAFLEX® membranes are derived from porcine pericardium through careful purificati |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COLLAFLEX 90296975 not registered Live/Pending |
Collaflex 2020-11-03 |
COLLAFLEX 77325623 not registered Dead/Abandoned |
C. R. Bard, Inc. 2007-11-09 |