| Primary Device ID | 16975424191317 |
| NIH Device Record Key | 0767e111-e9b0-4b7d-95b2-b6eedb0ce550 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MakoMed |
| Version Model Number | MM2000 |
| Catalog Number | MM2000 |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06975424191310 [Primary] |
| GS1 | 16975424191317 [Package] Contains: 06975424191310 Package: Case [30 Units] In Commercial Distribution |
| GS1 | 26975424191314 [Package] Package: Case [3 Units] In Commercial Distribution |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-12 |
| Device Publish Date | 2023-04-04 |
| 16975424191355 | Band Bag with tape 127x91cm- 50"x36" |
| 16975424191348 | Band Bag with Tape and Elastic Bands 91x91cm |
| 16975424191331 | Band Bag with Tape and Elastic Bands 91x56 cm - 36" x 22" |
| 16975424191324 | Probe Cover , VIP film , Gel and Elastic Bands 13x122cm |
| 16975424191317 | Probe Cover , VIP film , Gel and Elastic Bands 13x61cm |
| 16975424191300 | Microscope Drape - Zeiss MD 117x203cm |
| 16975424191294 | Microscope Drape - Leica 137 x 381 cm |
| 16975424191287 | Microscope Drape- Zeiss MD, 137x381cm - 54"x150" |