| Primary Device ID | 00850015378539 |
| NIH Device Record Key | 1a93e737-6654-4679-b71f-d1fb0ffaf3c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Exact Medical Manufacturing |
| Version Model Number | E104050 |
| Catalog Number | E104050 |
| 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 | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00852205007847 | E5937 |
| 20852205007971 | Microscope Drape-Leica, Bayonet, 137x381cm - 54"x150" |
| 10852205007950 | Sterile Dual Fenstrated Drape |
| 00852205007946 | Microscope Drape, Leica 137x381cm – 54” x 150” |
| 00852205007915 | EP5512 |
| 00850015378294 | Probe Cover, 14 x 29.2, Kit, VIP Film w/ Elastic Bands & EMM Gel |
| 00850015378539 | Surgical Gown, Large, AAMI 4 HaloGuard |
| 00850024023017 | C-Arm Drape 107x165cm |
| 00850033380606 | Sheet 140cmx140cm Kit Pack Fold |
| 00850033380583 | Sheet 140cmx140cm Fan Fold |
| 00850033380569 | Sheet 120cmx120cm Kit Pack Fold |
| 00850033380545 | Sheet 120cmx120cm Fan Fold |
| 00850033380521 | Sheet 90cmx90cm Kit Pack Fold |
| 00850033380507 | Sheet 90cmx90cm Fan Fold |
| 00850033380620 | Micromate Needle Guide Set/Device Cover PE w Needle Guide 8G-11G Elastic Band 35x110cm |
| 00850033380675 | Femoral Drape 220x380cm |
| 00850033380651 | Reinforced BTC |
| 00850033380712 | Robot Drape |
| 00850033380743 | Screen Cover with cuff 34x76cm |
| 00850033380767 | Dome Bag 18cm - 7" |
| 00850033380781 | C-Arm Drape with Clips 41x230cm - 16"x91" |
| 00850033380811 | Drape, PU, 60x60cm round fen 6cm with Adhesive |
| 00816953024358 | C-Arm Drape 224X107cm - 88"x42" |
| 00850033380842 | Probe Cover, VIP film, Gel, Elastic bands 15x91cm - 6"x36" |
| 10850033380887 | Sponge Counter Bag Rack |
| 00850037124008 | Drape 90x90cm, Fenestration 10cm round ADH, Bi-Laminate |
| 00850037124022 | C-Arm Kit XLVI (46) |
| 06975085709206 | Micromate Tracker and Drape |
| 16975085708534 | Micromate Needle Guide Set/Device Cover PE w Needle Guide 8G-11G Elastic Band 35x110cm |
| 16975085708817 | Probe Cover, PE, Gel and Elastic bands, 6"x96" |
| 16975085708503 | Drape for VITOM® eagle (TH201) |
| 26975085708357 | Surgical Gown, X-Large, Fabric Reinf. AAMI 3 |
| 26975085708340 | Surgical Gown, Large, Fabric Reinf. AAMI 3 |
| 16975085706103 | Sterile Drape CCU 25cm wide x 100cm long |
| 16975085706073 | Device Cover PE w Needle Guide 11G-14G Elastic Band 35x110cm |
| 16975085706066 | Device Cover PE w Needle Guide 15G-21G Elastic Band 35x110cm |
| 16975424191515 | Probe Cover Polyurethane |
| 16975424191508 | Probe Cover Polyurethane |
| 16975085703744 | EXPLORER AIR® Sterile Drape |
| 16975424193359 | Probe Cover, VIP film, Gel & Elastic bands 15x122cm-6"x48" |
| 16975424193342 | Probe Cover, PE, Gel and Elastic bands 15x122cm, 6"x48" |
| 16975424194554 | Micromate Control Unit Drape |
| 16975424194547 | Micromate Needle Guide 8-11G |
| 16975424194530 | Micromate Needle Guide 15-21G |
| 16975424194523 | Micromate Needle Guide 10-14G |
| 26975424194612 | Hemorrhage View C-Section Drape, sterile |
| 16975424195285 | Foot Switch Cover with drawstring 36x76cm - 14"x30" |
| 26975424195251 | Hemorrhage View C-Section Drape,Sterile, full incision panel |
| 26975424195237 | Hemorrhage View C-Section Drape, Sterile, Pear Shaped fenestration within incision panel |
| 16975424195391 | Remote Control Cover 125x260mm |