CollaFlex C07-0101
GUDID D767C0701010
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 ID | D767C0701010 |
| NIH Device Record Key | 26df1ff8-ab22-49fc-a0a8-75aa408b1010 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CollaFlex |
| Version Model Number | 15mm x 20mm |
| Catalog Number | C07-0101 |
| 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 |
Customer Support Contacts
| 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 Dimensions
| 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 |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D767C0701010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200623
FDA Product Code
| NPL | Barrier, Animal Source, Intraoral |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-10-14 |
| Device Publish Date | 2024-01-10 |
On-Brand Devices [CollaFlex]
| 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 |
Trademark Results [CollaFlex]
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 |
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