| Primary Device ID | 00813909011639 |
| NIH Device Record Key | 139e44cd-06a6-48dc-8bce-a59b9888902b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IRM - 1.0cc |
| Version Model Number | NP0601 |
| Catalog Number | NP0601 |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813909011639 [Primary] |
| MQV | Filler, Bone Void, Calcium Compound |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-01 |
| 00813909012988 - Dispenser MIS Cartridge | 2024-08-29 Dispenser used with synthetic bone void filler for orthopedic applications |
| 00813909012995 - Putty MIS System 10.0cc | 2024-08-29 Synthetic bone void filler for orthopedic applications |
| 00813909013091 - Putty MIS System 10.0cc | 2024-08-29 Synthetic bone void filler for orthopedic applications |
| 00813909013008 - Putty 2.5cc | 2024-08-28 Synthetic bone void filler for orthopedic applications |
| 00813909013015 - Putty 5.0cc | 2024-08-28 Synthetic bone void filler for orthopedic applications |
| 00813909013022 - Bioactive Strip 5.0cc | 2024-08-28 Synthetic bone void filler for orthopedic applications |
| 00813909013039 - MacroPor-Si+ 8.0 cc | 2024-08-28 Synthetic bone void filler for orthopedic applications |
| 00813909013046 - Putty Syringe 2.5cc | 2024-08-28 Synthetic bone void filler for orthopedic applications |