| Primary Device ID | 00816953022057 |
| NIH Device Record Key | 7b77c6d3-1b5d-4642-8e83-b15a720c59d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E5303 Dome Bag 35cm - 14" |
| Version Model Number | E5303 |
| Catalog Number | E5303 |
| Company DUNS | 014464314 |
| Company Name | EXACT MEDICAL MANUFACTURING, INC. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| 16975424195988 - Exact Medical Manufacturing, Inc. | 2025-04-07 General Purpose Probe Cover (3D End), Gel, Bands 6" x 48" |
| 16975424195995 - Exact Medical Manufacturing, Inc. | 2025-04-07 C-Arm Drape Miniview 6600/6800, 48 x 84" |
| 06975424196001 - Exact Medical Manufacturing, Inc. | 2025-04-07 General Purpose Probe Cover 5" x 48" (13cm x 122cm) |
| 16975424196015 - Exact Medical Manufacturing, Inc. | 2025-04-07 Intraoperative Probe Cover w/ Gel 5" x 96" (13cm x 244cm) |
| 26975424196067 - Exact Medical Manufacturing, Inc. | 2025-04-07 Microscope Cover Mitaka MM51 |
| 26975424196074 - Exact Medical Manufacturing, Inc. | 2025-04-07 Microscope Drape For Zeiss OPMI 41" x 80" |
| 16975424196084 - Exact Medical Manufacturing, Inc. | 2025-04-07 Microscope Drape- Zeiss MD 112x300cm - 44"x118" |
| 26975424196098 - Exact Medical Manufacturing, Inc. | 2025-04-07 Intraoperative Large T-Shaped Probe Cover w/ Gel 6" x 96" |