| Primary Device ID | 00850009685384 |
| NIH Device Record Key | d54860d8-604e-4286-8520-7da97b40c3b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amplify |
| Version Model Number | AMP-018 |
| Company DUNS | 081127567 |
| Company Name | Ventris Medical |
| 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 |
| Phone | 949-706-5551 |
| info@ventrismedical.com | |
| Phone | 949-706-5551 |
| info@ventrismedical.com | |
| Phone | 949-706-5551 |
| info@ventrismedical.com | |
| Phone | 949-706-5551 |
| info@ventrismedical.com | |
| Phone | 949-706-5551 |
| info@ventrismedical.com | |
| Phone | 949-706-5551 |
| info@ventrismedical.com | |
| Phone | 949-706-5551 |
| info@ventrismedical.com | |
| Phone | 949-706-5551 |
| info@ventrismedical.com | |
| Phone | 949-706-5551 |
| info@ventrismedical.com | |
| Phone | 949-706-5551 |
| info@ventrismedical.com | |
| Phone | 949-706-5551 |
| info@ventrismedical.com | |
| Phone | 949-706-5551 |
| info@ventrismedical.com |
| Weight | 1.875 Gram |
| Weight | 1.875 Gram |
| Weight | 1.875 Gram |
| Weight | 1.875 Gram |
| Weight | 1.875 Gram |
| Weight | 1.875 Gram |
| Weight | 1.875 Gram |
| Weight | 1.875 Gram |
| Weight | 1.875 Gram |
| Weight | 1.875 Gram |
| Weight | 1.875 Gram |
| Weight | 1.875 Gram |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00850009685384 [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 | 2025-08-06 |
| Device Publish Date | 2025-07-29 |
| 00850009685254 | Surface Activated Bone Putty, Amplify, Large |
| 00850009685247 | Surface Activated Bone Putty, Amplify, Medium |
| 00850009685230 | Surface Activated Bone Putty, Amplify Small |
| 00850009685384 | Surface Activated Bone Putty, Amplify X-Small |