ARTISS Fibrin Sealant is a Topical Solution in the Plasma Derivative category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Fibrinogen Human; Human Thrombin.
| Product ID | 0338-9639_74bb54d7-5945-4f63-aedb-69fd113d5409 |
| NDC | 0338-9639 |
| Product Type | Plasma Derivative |
| Proprietary Name | ARTISS Fibrin Sealant |
| Generic Name | Fibrinogen Human, Human Thrombin |
| Dosage Form | Solution |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2008-03-19 |
| Marketing Category | BLA / |
| Application Number | BLA125266 |
| Labeler Name | Baxter Healthcare Corporation |
| Substance Name | FIBRINOGEN HUMAN; HUMAN THROMBIN |
| Active Ingredient Strength | 87 mg/mL; [iU]/mL |
| Pharm Classes | Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2008-03-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0338-8503 | ARTISS | Fibrinogen Human, Human Thrombin |
| 0338-9637 | ARTISS | Fibrinogen Human, Human Thrombin |
| 0338-9639 | ARTISS | Fibrinogen Human, Human Thrombin |
| 0338-4210 | TISSEEL | fibrinogen human, human thrombin |
| 0338-4211 | TISSEEL | fibrinogen human, human thrombin |
| 0338-4212 | TISSEEL | fibrinogen human, human thrombin |
| 0338-4301 | TISSEEL | fibrinogen human, human thrombin |
| 0338-4302 | TISSEEL | fibrinogen human, human thrombin |
| 0338-4303 | TISSEEL | fibrinogen human, human thrombin |
| 0338-8402 | TISSEEL | fibrinogen human, human thrombin |
| 0338-9560 | TISSEEL | fibrinogen human, human thrombin |
| 0338-9564 | TISSEEL | fibrinogen human, human thrombin |
| 0338-9568 | TISSEEL | fibrinogen human, human thrombin |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ARTISS 78514937 3502970 Live/Registered |
Baxter International Inc. 2004-11-10 |