Primary Device ID | 04547410327359 |
NIH Device Record Key | 069aef09-ee96-40de-bed5-c4947dd79849 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lateral Approach Kit |
Version Model Number | LATERAL BIOPSY KIT HA USA E |
Company DUNS | 713565195 |
Company Name | FUJIFILM CORPORATION |
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 | true |
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 | false |
OTC Over-The-Counter | false |
Phone | +018002728465 |
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Phone | +018002728465 |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 04547410327359 [Primary] |
MUE | Full field digital,system,x-ray,mammographic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-12-14 |
04547410530582 - DR-ID 1281SE | 2024-09-09 The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the d |
04547410530599 - DR-ID 1282SE | 2024-09-09 The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the d |
04547410530605 - DR-ID 1283SE | 2024-09-09 The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the d |
04547410530612 - DR-ID 1284SE | 2024-09-09 The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the d |
04547410530629 - DR-ID 1285SE | 2024-09-09 The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the d |
04547410530636 - DR-ID 1280MP | 2024-09-09 The DR-ID 1280MP supplies the power to the flat panel sensor connected by a medical professional and establishes intercommunicat |
04547410530643 - DR-ID 1280PB | 2024-09-09 The DR-ID 1280PB supplies the power to the flat panel sensor connected by a medical professional and establishes intercommunicat |
04547410530650 - Li-Polymer Battery Pack | 2024-09-09 The product is used to supply power for SE. |