Primary Device ID | 04547410316902 |
NIH Device Record Key | 5fb43552-91f7-4e09-bb1a-9411bf40d87f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AWS-h |
Version Model Number | FDR-3000AWS |
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 | 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 | false |
OTC Over-The-Counter | false |
Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
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Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx | |
Phone | +018002728465 |
xxx@xxx.xxx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04547410316902 [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 | 2016-09-16 |
14547410491712 - FUJIFILM | 2024-07-15 "This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagno |
14547410514053 - FUJIFILM | 2024-07-15 This product is intended to be used as an accessory with the FUJIFILM Double Balloon Endoscope cleared for use with an Over-tube |
04547410431957 - DRYPIX Smart | 2024-06-17 The DRYPIX Smart is a device that prints digital image data, transferred via the DICOM network from the FCR/FDR Image Reader or |
04547410538861 - FCR 1Shot Phantom Plus | 2024-06-17 1 Shot Phantom Plus is used for quality control of digital Radiography systems. |
14547410520542 - FUJIFILM | 2024-05-23 Endoscope Model EB-710XT is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and b |
04547410541199 - FUJIFILM | 2024-02-26 This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as pol |
04547410509984 - FUJIFILM | 2024-01-04 This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and s |
04547410509991 - FUJIFILM | 2024-01-04 This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and s |