| Primary Device ID | 07630031730015 |
| NIH Device Record Key | c5be8dbe-9562-420f-985d-fdbc9a6c68f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Straumann Emdogain |
| Version Model Number | Emdogain |
| Catalog Number | 075.114W |
| Company DUNS | 483599259 |
| Company Name | Institut Straumann AG |
| Device Count | 3 |
| 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 | 1 800 4488168 |
| info.usa@straumann.com |
| Total Volume | 0.9 Milliliter |
| Total Volume | 1.8 Milliliter |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630031730015 [Primary] |
| GS1 | 07630031747006 [Unit of Use] |
| NQA | Biologic Material, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-14 |
| Device Publish Date | 2019-03-06 |
| 07630031730046 | Straumann Emdogain, 5 x 0.7 ml (30mg/ml) |
| 07630031730039 | Straumann Emdogain, 5 x 0.3 ml (30 mg/ml) |
| 07630031730022 | Straumann Emdogain Multipack, Straumann Emdogain 3 x 0.7 ml (30 mg/ml), Straumann PrefGel 3 x 0. |
| 07630031730015 | Straumann Emdogain Multipack, Straumann Emdogain 3 x 0.3 ml (30 mg/ml), Straumann PrefGel 3 x 0. |
| 07630031729989 | Straumann Emdogain, 5 x 0.15 ml (30 mg/ml) |
| 07630031747389 | Straumann Emdogain MI 0.3ml |
| 07630031747372 | Straumann Emdogain MI 0.15ml |