| Primary Device ID | 07640173234111 |
| NIH Device Record Key | 1be3e6b9-7bdc-427f-af65-003127c22ace |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RHA® 2 |
| Version Model Number | RHA® 2 - Terumo - US |
| Catalog Number | 940103 |
| Company DUNS | 482411860 |
| Company Name | Teoxane SA |
| 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 | true |
| Device Combination Product | true |
| 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 | 877-373-8669 |
| Medical-us@teoxane.com | |
| Phone | 877-373-8669 |
| Medical-us@teoxane.com | |
| Phone | 877-373-8669 |
| Medical-us@teoxane.com | |
| Phone | 877-373-8669 |
| Medical-us@teoxane.com | |
| Phone | 877-373-8669 |
| Medical-us@teoxane.com | |
| Phone | 877-373-8669 |
| Medical-us@teoxane.com | |
| Phone | 877-373-8669 |
| Medical-us@teoxane.com | |
| Phone | 877-373-8669 |
| Medical-us@teoxane.com | |
| Phone | 877-373-8669 |
| Medical-us@teoxane.com | |
| Phone | 877-373-8669 |
| Medical-us@teoxane.com | |
| Phone | 877-373-8669 |
| Medical-us@teoxane.com | |
| Phone | 877-373-8669 |
| Medical-us@teoxane.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (up to 25°C / 77°F). Do not expose to direct sunlight. Do not freeze. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640173234111 [Package] Contains: 07640173234128 Package: box [2 Units] In Commercial Distribution |
| GS1 | 07640173234128 [Primary] |
| LMH | Implant, Dermal, For Aesthetic Use |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-01 |
| Device Publish Date | 2024-03-22 |
| 07640173230021 | One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a 1 |
| 07640173233671 | "One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a |
| 07640173233732 | "One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a |
| 07640173234234 | "One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a |
| 07640173234111 | "One box of RHA® 2 contains two blisters and one instruction for use. Each blister contains a |