| Primary Device ID | 00813909014005 |
| NIH Device Record Key | 9ba11ea5-a2fe-452b-845a-acd3fcffea98 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Putty Syringe with Cannula 10.0cc |
| Version Model Number | NB6510 |
| Catalog Number | NB6510 |
| Company DUNS | 828813290 |
| Company Name | NOVABONE PRODUCTS, LLC |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813909014005 [Primary] |
| MQV | Filler, Bone Void, Calcium Compound |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-05 |
| Device Publish Date | 2026-01-28 |
| 00813909013985 - Putty Syringe with Cannula 2.5cc | 2026-02-05 Synthetic bone void filler for orthopedic applications |
| 00813909013992 - Putty Syringe with Cannula 5.0cc | 2026-02-05 Synthetic bone void filler for orthopedic applications |
| 00813909014005 - Putty Syringe with Cannula 10.0cc | 2026-02-05Synthetic bone void filler for orthopedic applications |
| 00813909014005 - Putty Syringe with Cannula 10.0cc | 2026-02-05 Synthetic bone void filler for orthopedic applications |
| 00813909013961 - Putty Syringe 2.5cc | 2026-01-19 Synthetic bone void filler for orthopedic applications |
| 00813909013978 - Putty Syringe 5.0cc | 2026-01-19 Synthetic bone void filler for orthopedic applications |
| 00813909013909 - Putty 2.5cc | 2026-01-05 Synthetic bone void filler for orthopedic applications |
| 00813909013916 - Putty 5.0cc | 2026-01-05 Synthetic bone void filler for orthopedic applications |
| 00813909013923 - Porous Morsels 1-2mm 5.0cc | 2026-01-05 Synthetic bone void filler for orthopedic applications |