Primary Device ID | 04056869250144 |
NIH Device Record Key | 2e41ea60-65c4-4c87-841e-e6dd1777e698 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | syngo Utrasound Breast Analysis |
Version Model Number | 11507859 |
Company DUNS | 804722783 |
Company Name | SIEMENS MEDICAL SOLUTIONS USA, 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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04056869250144 [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 | 2023-07-07 |
Device Publish Date | 2023-06-29 |
04056869961064 - Sparrow HP2 3 Ring | 2024-02-08 |
04056869961071 - Sparrow HP2 4 Ring | 2024-02-08 |
04056869961088 - Sparrow HP4 3 Ring | 2024-02-08 |
04056869961095 - Sparrow HP4 4 Ring | 2024-02-08 |
04056869973852 - 5Z1 Transducer | 2024-01-25 |
04056869973869 - Z6T Transducer | 2024-01-25 |
04056869996295 - ACUSON Origin Diagnostic Ultrasound System | 2023-12-27 |
04056869279800 - syngo MBF | 2023-12-15 |