| Primary Device ID | 20805832070030 |
| NIH Device Record Key | 03ebab8b-7b1d-498f-b811-fab4f0fbf2ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NDI Passive Sphere |
| Version Model Number | 8801075 |
| Catalog Number | 8801075 |
| Company DUNS | 241987692 |
| Company Name | Northern Digital 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 519-884-5142 |
| spheres@ndigital.com | |
| Phone | 519-884-5142 |
| spheres@ndigital.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00805832070036 [Primary] |
| GS1 | 20805832070030 [Package] Contains: 00805832070036 Package: Tray in Pouch [12 Units] In Commercial Distribution |
| HAW | Neurological Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 00805832070043 | Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri |
| 20805832070030 | Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri |
| 20805832070023 | Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri |
| 20805832070016 | Disposable Reflective Spheres attached to reference frames and surgical instruments for use duri |