| Primary Device ID | 00858686006065 |
| NIH Device Record Key | a3e49bb0-6d03-40ed-8376-85d706b10a30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bio V BP Bioactive Glass with DBM Putty - 5.0 cc |
| Version Model Number | BGP001-05 |
| Catalog Number | BGP001-05 |
| Company DUNS | 080131031 |
| Company Name | AMEND SURGICAL, 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 | true |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com | |
| Phone | 8442813169 |
| smathison@amendsurgical.com |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Humidity | Between 1 Degrees Celsius and 37 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858686006065 [Primary] |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) |
| 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 | 2017-11-10 |
| 00858686006089 - NanoFUSE Bioactive Strip | 2019-07-24 Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantation |
| 00858686006096 - NanoFUSE Bioactive Strip | 2019-07-24 Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantation |
| 00858686006003 - NanoFuse Bioactive Matrix - 2.0 cc | 2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications |
| 00858686006010 - NanoFuse Bioactive Matrix - 5.0 cc | 2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications |
| 00858686006027 - NanoFuse Bioactive Matrix - 10.0 cc | 2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications |
| 00858686006034 - NanoFuse Bioactive Matrix - 1.0 cc | 2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser |
| 00858686006041 - Bio V BP Bioactive Glass with DBM Putty | 2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser |
| 00858686006058 - Bio V BP Bioactive Glass with DBM Putty - 2.0 cc | 2018-07-06 Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser |