| Primary Device ID | 00813909013572 |
| NIH Device Record Key | a5f18314-25ca-4ff7-8f4e-df3b6f220cf1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dental Putty Cartridge 4 x 0.25cc |
| Version Model Number | ND4640 |
| Catalog Number | ND4640 |
| Company DUNS | 828813290 |
| Company Name | NOVABONE PRODUCTS, LLC |
| Device Count | 4 |
| 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 |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813909013510 [Primary] |
| GS1 | 00813909013572 [Unit of Use] |
| LYC | Bone Grafting Material, Synthetic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-05 |
| Device Publish Date | 2025-04-25 |
| 00813909010328 - Dental Porous Morsels 2x0.5g | 2025-07-25 Synthetic bone void filler for dental applications |
| 00813909013756 - Dental Porous Morsels 2x1.5g | 2025-07-25 Synthetic bone void filler for dental applications |
| 00813909013701 - Bioactive Strip 10.0cc Long | 2025-07-17 Synthetic bone void filler for orthopedic applications |
| 00813909013718 - IRM - 2.5cc | 2025-07-17 Synthetic bone void filler for orthopedic applications |
| 00813909013725 - IRM - 5.0cc | 2025-07-17 Synthetic bone void filler for orthopedic applications |
| 00813909013732 - IRM - 10.0cc | 2025-07-17 Synthetic bone void filler for orthopedic applications |
| 00813909013152 - Putty 2.5cc | 2025-07-01 Synthetic bone void filler for orthopedic applications |
| 00813909013169 - Putty 5.0cc | 2025-07-01 Synthetic bone void filler for orthopedic applications |