| Primary Device ID | EAMIRAR20110 |
| NIH Device Record Key | dc638737-391e-4251-a880-9bf75757a00a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A.M.I. Recto Anal Repair Probe |
| Version Model Number | RAR 2011 |
| Catalog Number | RAR 2011 |
| Company DUNS | 303655286 |
| Company Name | AMI Agency for Medical Innovations GmbH |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EAMIRAR20110 [Primary] |
| HIBCC | EAMIRAR20111 [Package] Package: [5 Units] In Commercial Distribution |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-04-12 |
| Device Publish Date | 2018-11-28 |
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