EOSedge™
GUDID 03663999000108
EOS IMAGING
Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital| Primary Device ID | 03663999000108 |
| NIH Device Record Key | f0e1b9dd-0541-483c-b61f-afbdc8cc5f81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EOSedge™ |
| Version Model Number | 4.0 |
| Company DUNS | 762320968 |
| Company Name | EOS IMAGING |
| 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 |
Customer Support Contacts
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com | |
| Phone | 866-933-5301 |
| contact@eos-imaging.com |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03663999000108 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| KPR | System, X-Ray, Stationary |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-06 |
| Device Publish Date | 2020-02-27 |
Devices Manufactured by EOS IMAGING
| 03663999000184 - spineEOS | 2024-02-23 |
| 03663999000153 - sterEOS | 2024-02-22 |
| 03663999000061 - Radiolucent Chair | 2023-07-18 |
| 03663999000160 - spineEOS | 2023-07-18 |
| 03663999000177 - hipEOS | 2023-07-18 |
| 03663999000191 - EOS Portal | 2023-07-18 |
| 03663999000108 - EOSedge™ | 2020-03-06 |
| 03663999000108 - EOSedge™ | 2020-03-06 |
| 03663999000009 - EOS® | 2020-02-28 |
Trademark Results [EOSedge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EOSEDGE 97438566 not registered Live/Pending |
EOS Imaging SA 2022-06-01 |
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