| Primary Device ID | 00358468000071 |
| NIH Device Record Key | dce63616-d3f8-410d-bb3d-35633a4e20e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US |
| Version Model Number | 762617 |
| Company DUNS | 050424395 |
| Company Name | GENZYME CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Manufacturing Date | false |
| 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 |
| 00358468000071 - GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US | 2022-10-27GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US |
| 00358468000071 - GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US | 2022-10-27 GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US |
| 00358468000057 - NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U | 2020-07-09 NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U |
| 00358468000064 - OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US | 2020-07-09 OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US |
| 00358468430120 - Seprafilm® | 2019-09-10 Barrier, Absorbable, Adhesion |
| 00358468508621 - Seprafilm® Procedure Pack | 2019-09-10 Barrier, Absorbable, Adhesion |
| 00358468638014 - Seprafilm® 4-section | 2019-09-10 Barrier, Absorbable, Adhesion |
| 00358468664112 - Seprafilm® Single Site | 2019-09-10 Barrier, Absorbable, Adhesion |
| 00358468664211 - Seprafilm® Small Incision | 2019-09-10 Barrier, Absorbable, Adhesion |