| Primary Device ID | 00866955000416 |
| NIH Device Record Key | 01b2817a-74c4-45da-a764-a40b67bc9a6e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XR-600 Clinical |
| Version Model Number | 600 |
| Company DUNS | 110329096 |
| Company Name | Norland at Swissray |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 920-563-8456 |
| pat.cunniff@swissray.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00866955000416 [Primary] |
| KGI | Densitometer, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-11-16 |
| 00860008461209 - uREzpocus | 2022-05-03 Ultrasonic pulsed doppler imaging system - Convex HD array |
| 00860008461216 - uREzpocus | 2022-05-03 Ultrasonic pulsed doppler imaging system - uREzpocus H |
| 00860008461223 - uREzpocus | 2022-05-03 Ultrasonic pulsed doppler imaging system - MicroConvex array |
| 00866955000485 - uREzpocus | 2021-03-23 Convex probe. |
| 00866955000492 - uREzpocus | 2021-03-23 Linear probe. |
| 00866955000478 - IlluminatusDXA Software | 2020-08-04 |
| 00866955000409 - XR-600 Basic | 2018-07-06 XR-600 Basic Bone Densitometer |
| 00866955000416 - XR-600 Clinical | 2018-07-06XR-600 Clinical Bone Desitometer |
| 00866955000416 - XR-600 Clinical | 2018-07-06 XR-600 Clinical Bone Desitometer |