Primary Device ID | 00815212026843 |
NIH Device Record Key | cbf25dc5-5ece-4532-ad46-a684a7f74047 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ONPOINT SPHERZ PASSIVE MARKER-12 PACK |
Version Model Number | DS0211201 |
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 | true |
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 |