Primary Device ID | 03770019599082 |
NIH Device Record Key | cd3c4e5f-688e-436e-806c-d332e930ca5d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | inHEART MODELS Shaper |
Version Model Number | v1.8.0 |
Company DUNS | 269837780 |
Company Name | INHEART |
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 | true |
Serial Number | false |
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 |
---|---|
GS1 | 03770019599082 [Primary] |
QIH | Automated Radiological Image Processing Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-16 |
Device Publish Date | 2024-04-08 |
03770019599013 | inHEART Models Shaper is a medical image processing and visualization software for manual 3D seg |
03770019599082 | inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D mode |
03770019599037 | inHEART MODELS Shaper is a standalone image processing software used to generate digital 3D mode |