Primary Device ID | 00850008541155 |
NIH Device Record Key | 6c6cdfae-fac0-46f7-9ba3-f39c51e2221e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Internal Hexagon |
Version Model Number | I3SP0837 |
Company DUNS | 026108395 |
Company Name | I3 IMPLANT 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 |