REGENAFILL RFP6X25
GUDID 10813954026180
Bone Graft Plug
COLLAGEN MATRIX, INC.
Dental bone matrix implant, synthetic| Primary Device ID | 10813954026180 |
| NIH Device Record Key | 62f1f974-7167-458d-a44b-2d14cbba4c21 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REGENAFILL |
| Version Model Number | RFP6X25 |
| Catalog Number | RFP6X25 |
| 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 | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.com | |
| Phone | (833) 701-5245 |
| clinic@surgicalesthetics.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 |
| 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 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 |
| 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 | 00813954026183 [Primary] |
| GS1 | 10813954026180 [Package] Contains: 00813954026183 Package: Box [5 Units] In Commercial Distribution |
FDA Product Code
| NPM | Bone Grafting Material, Animal Source |
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 | 2024-07-01 |
| Device Publish Date | 2024-06-21 |
On-Brand Devices [REGENAFILL]
| 10813954026197 | Bone Graft Plug |
| 10813954026180 | Bone Graft Plug |
Trademark Results [REGENAFILL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REGENAFILL 98561239 not registered Live/Pending |
Surgical Esthetics 2024-05-21 |
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