OssiMend MCC2020-1
GUDID 00813954026831
Bone Graft Matrix
COLLAGEN MATRIX, INC.
Bone matrix implant, animal-derived, bioabsorbable| Primary Device ID | 00813954026831 |
| NIH Device Record Key | 96ff5d2d-13e9-4c90-b21d-972d94b6c18f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OssiMend |
| Version Model Number | MCC2020-1 |
| Catalog Number | MCC2020-1 |
| Company DUNS | 176262442 |
| Company Name | COLLAGEN MATRIX, 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 | false |
| 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 | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.com | |
| Phone | (201) 405-1477 |
| contact@regenity.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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813954026831 [Primary] |
FDA Product Code
| MQV | Filler, Bone Void, Calcium Compound |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-27 |
| Device Publish Date | 2025-03-19 |
On-Brand Devices [OssiMend]
| 00813954022130 | Bone Graft Matrix, 2 strips (5cc each), 2x5x0.5cm strip |
| 00813954022123 | Bone Graft Matrix, 2 pads (2cc each), 2x2x0.5cm pad |
| 00813954022109 | Bone Graft Matrix, 1 pad (2cc), 2x2x0.5cm pad |
| 00813954020815 | Bone Graft Matrix |
| 00813954020808 | Bone Graft Matrix |
| 00813954020310 | Bone Graft Matrix |
| 00813954026848 | Bone Graft Matrix |
| 00813954026831 | Bone Graft Matrix |
| 00813954026824 | Bone Graft Matrix |
Trademark Results [OssiMend]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSIMEND 85657931 4282934 Live/Registered |
Collagen Matrix, Inc. 2012-06-21 |
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