| Primary Device ID | 00815212020414 |
| NIH Device Record Key | 7ecb2286-0eed-4a89-9811-d3a41dffa719 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Threaded Spherz |
| Version Model Number | TS2001 |
| Company DUNS | 933506164 |
| Company Name | Izi Medical Products, LLC |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815212020414 [Primary] |
| HAW | Neurological Stereotaxic Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-10 |
| 00815212021565 | 2020-40 |
| 00815212021558 | 2020-160 |
| 00815212021541 | 2020-130 |
| 00815212021534 | 2020-120 |
| 00815212021527 | 2020-100 |
| 00815212021510 | 2020-04 |
| 00815212021503 | 2020-03 |
| 00815212021497 | 2020-02 |
| 00815212021480 | 2020-01 |
| 00815212020469 | TS2090 |
| 00815212020452 | TS2005 |
| 00815212020445 | TS2004 |
| 00815212020438 | TS2003 |
| 00815212020421 | TS2002 |
| 00815212020414 | TS2001 |
| 00815212020407 | TS1010 |
| 00815212024436 | 2020-120-CAS |