| Primary Device ID | 07630031747389 |
| NIH Device Record Key | af8fb999-2825-4be1-b461-54fd94e7a9b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Straumann Emdogain |
| Version Model Number | Emdogain |
| Catalog Number | 075.133 |
| Company DUNS | 483599259 |
| Company Name | Institut Straumann AG |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(801)448-8168 |
| info.usa@straumann.com |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.6 Milliliter |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630031747389 [Primary] |
| 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 | 2020-08-14 |
| Device Publish Date | 2020-08-06 |
| 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 |