| Primary Device ID | 00816953022170 |
| NIH Device Record Key | 4bd2cf25-16e2-4c90-badb-0ea2ab2b73b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E5316 Dome Bag 80cm - 31" |
| Version Model Number | E5316 |
| Catalog Number | E5316 |
| 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 |
| 26975424197965 - Exact Medical Manufacturing, Inc. | 2025-07-29 Hemorrhage View C-Section Drape, Sterile, full Inc,Matern sn |
| 26975424197989 - Exact Medical Manufacturing, Inc. | 2025-07-29 Hemorrhage View C-Section Drape, Sterile,Pear Shp,Matern sn |
| 16975085703041 - Exact Medical Manufacturing, Inc. | 2025-07-11 Microscope Drape- Leica 137x381cm - 54"x150" |
| 26975424196746 - Exact Medical Manufacturing, Inc. | 2025-06-27 Closed System Camera Drape, with adhesive at open end, 7 x 9 |
| 26975424196906 - Exact Medical Manufacturing, Inc. | 2025-06-27 Patient Isolation Drape 96" x 130" |
| 26975424197729 - Exact Medical Manufacturing, Inc. | 2025-06-27 Drape for Mitaka MM90 Surgical Microscope |
| 26975424197750 - Exact Medical Manufacturing, Inc. | 2025-06-27 Leica Microscope Drape, 651 Push On 46" X 120" |
| 26975424197767 - Exact Medical Manufacturing, Inc. | 2025-06-27 Leica Microscope Drape, 650 Push On 54" X 150" |