Primary Device ID | B216FB910A40K1 |
NIH Device Record Key | 4a86820a-097d-40d0-ae99-b793f28fe262 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | X-CEL X-RAY CORPORATION |
Version Model Number | FB910A-40K |
Company DUNS | 062469945 |
Company Name | ARQUILLA, INC. |
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 | 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 |
Phone | 8154552470 |
guido@xcelxray.com | |
Phone | 8154552470 |
guido@xcelxray.com |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Handling Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B216FB910A40K1 [Primary] |
KPR | System, X-Ray, Stationary |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-01-06 |
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