Primary Device ID | B885MAML2US0 |
NIH Device Record Key | c1a5945a-26a8-483a-9c96-2aa7efc4636d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MammoScreen |
Version Model Number | MAL2US |
Company DUNS | 265235524 |
Company Name | THERAPIXEL |
Device Count | 1 |
DM Exempt | true |
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 | false |
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 |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com | |
Phone | +33625467635 |
support@therapixel.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B885MAML2US0 [Primary] |
QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-01-28 |
Device Publish Date | 2022-01-20 |
B885MAML0 | Radiological computer assisted detection and diagnosis software |
B885MAML2US0 | Radiological computer assisted detection and diagnosis software |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MAMMOSCREEN 88423365 not registered Live/Pending |
Therapixel SA 2019-05-09 |
![]() MAMMOSCREEN 73686955 1524771 Dead/Cancelled |
HEALTH CARE RESOURCES, INC. 1987-09-29 |