| Primary Device ID | 00816953022545 |
| NIH Device Record Key | e91f32c5-ea12-4dd5-9f56-74d9d542cf08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Exact Medical |
| Version Model Number | E5431 |
| Catalog Number | E5431 |
| Company DUNS | 014464314 |
| Company Name | EXACT MEDICAL MANUFACTURING, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| OTC Over-The-Counter | true |
| 00850024023130 | Robot Arm Sterile Drape |
| 00816953022545 | Band Bag with Tape & Elastic 91x91cm |
| 00850024023215 | Microscope Drape, Leica, Bayonet, 137x381cm - 54" x 150" |
| 00850024023321 | Robot Arm Sterile Drape |
| 00850024023529 | Arthroscopy Surgical T-Drape with Fluid Control Pouch |
| 00850024023505 | Under Buttock Drape w Pouch & Backing |
| 00850024023482 | Lithotomy Pack |
| 00850024023468 | Abdominal Pack |
| 00850024023444 | Universal Split Pack |
| 00850024023420 | Universal Pack |
| 00850024023581 | Gown, Surgical AAMI Level 4 XX-Large w/ Towel |
| 00850024023567 | Gown, Surgical AAMI Level 4 X-Large w/ Towel |
| 00850024023543 | Gown, Surgical AAMI Level 4 Large w/ Towel |
| 00850024023604 | Drape for VITOM® Eagle |
| 00850024023741 | Drill Cover, cardboard insert, 8.5x175cm 3.3"x69" |
| 00850024023727 | Band Bag Nose Shape 89x120cm - 35"x47" |
| 00850031271029 | Band Bag, nose shaped, 80cm x 45cm - 32'' x 18'' |
| 00850024023888 | Band Bag 85cmx150cm - 34"x 59" |
| 00850024023864 | Microscope Drape, Zeiss MD, 117x203cm - 46"x80" |
| 00850024023826 | Universal Handle Cover Microscope pack of 2 |
| 00850024023802 | Microscope Drape, Zeiss MD, 117x305cm - 46"x120" |
| 00850024023765 | Camera Drape, Perf.Tip, Cardboard Insert, 18x244cm - 7"x96" |
| 00850031271074 | Dome Bag 90 cm - 35" |
| 00850031271098 | Stockinette 16x121cm - 6" x 48" |
| 00850031271210 | Stockinette, Rolled, Stretchable 30x121cm |
| 00850031271234 | Cover for Vision System 62x300cm |
| 00850031271395 | C-Arm Kit Ziehm V (5) |
| 00850031271364 | C-Arm Ziehm Kit IV (4) |
| 00850031271319 | C-Arm Kit Ziehm I (1) |
| 00850031271333 | User Interface Cover Ziehm |
| 00850031271265 | Disposable Cover Image Amplifier |
| 00850031271609 | Cover for X-Ray shield 105x110cm - 41"x43" |
| 00850031271579 | Gusseted Bag with Elastic 80x80x24cm - 32"x32"x10" |
| 00850031271517 | C-Arm Kit for Zeego 5-parts |
| 00850031271487 | Foot Switch Cover, Drawstring and adjuster 56x51cm - 22"x20" |
| 00850031271449 | Dome Bag 40cmx160cm - 16"x63" |
| 00850031271418 | C-Arm Kit Ziehm II (2) |
| 00850031271715 | Probe Cover, VIP film,Gel and Elastic bands 8x244cm-3"x96" |
| 00850031271777 | Foot Pedal Drape 17"x15" |
| 00850031271548 | C-Arm Kit for Zeego 7-parts |
| 00850031271937 | Stockinette, Rolled, Stretchable 30x121cm |
| 00850031271951 | Cassette Cover 61x56cm - 24"x22" |
| 00850031271920 | Stockinette, Rolled, Stretchable 30x121cm |
| 00816953023399 | Microscope Drape, Leica, 137x305cm- 54"x120" |
| 00850033380064 | Stockinette, Rolled, Stretchable 16x76cm - 6"x30" |
| 00850033380033 | Stockinette, Rolled, Stretchable 30x121cm - 12"x48" |
| 00850033380125 | Master Drape |
| 00850033380095 | Robot Drape |
| 00850033380156 | Drill Cover, two tapes, 8x120cm 3"x47" |
| 00850033380347 | Band Bag Nose Shaped 81x95cm - 32"x37" |