Primary Device ID | 00850008977473 |
NIH Device Record Key | d08aff7f-ba42-42b5-9504-3f5c964634a8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PowerLook Al Mammo Container- Blackford v1.0.0 |
Version Model Number | DSC036-01 |
Company DUNS | 108870254 |
Company Name | Icad, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
---|---|
GS1 | 00850008977473 [Primary] |
LMD | System, Digital Image Communications, 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 | 2023-07-24 |
Device Publish Date | 2023-07-14 |
00850008977527 - PowerLook 11.3 | 2023-08-10 |
00085000897751 - PowerLook Cloud 1.0 | 2023-07-25 |
00850008977442 - PowerLook 11.2 | 2023-07-24 |
00850008977459 - PowerLook Al Mammo Container - Radiology Partners v1.0.0 | 2023-07-24 |
00850008977466 - PowerLook Al Mammo Container- GE v1.1.0 | 2023-07-24 |
00850008977473 - PowerLook Al Mammo Container- Blackford v1.0.0 | 2023-07-24 |
00850008977473 - PowerLook Al Mammo Container- Blackford v1.0.0 | 2023-07-24 |
00850008977480 - PowerLook Al Mammo Container- Ferrum v1.0.0 | 2023-07-24 |
00850008977497 - PowerLook Al Mammo Container - Arterys v 1.2.0 | 2023-07-24 |