Primary Device ID | B334SY2P120 |
NIH Device Record Key | 9a2a6372-cfc1-422f-9c3b-39ab8e580b91 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Simplicit90Y |
Version Model Number | 2.12 |
Company DUNS | 211100325 |
Company Name | MIRADA MEDICAL LIMITED |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B334SY2P120 [Primary] |
LLZ | System, Image Processing, Radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-03-05 |
Device Publish Date | 2024-02-26 |
B334SY2P00 | 2.0 |
B334SY2P20 | 2.2 |
B334SY2P40 | 2.4 |
B334SY2P60 | 2.6 |
B334SY2P10 | 2.10 |
B334SY2P120 | 2.12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SIMPLICIT90Y 88232299 not registered Live/Pending |
Biocompatibles UK Limited 2018-12-17 |