| Primary Device ID | 03701089514194 |
| NIH Device Record Key | 6ec1a6f1-7d2e-4fe7-8274-c48c62da5ff1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VENTO Cup |
| Version Model Number | 1-01-12-3952 |
| Company DUNS | 634855407 |
| Company Name | AMPLITUDE SAS |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com | |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com | |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com | |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com | |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com | |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com | |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com | |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com | |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com | |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com | |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com | |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com | |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701089514194 [Primary] |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-09-09 |
| Device Publish Date | 2017-12-05 |