Celestial Star CS2050D-MRI
GUDID 00853538008068
Sunnex
Fixed examination/treatment light| Primary Device ID | 00853538008068 |
| NIH Device Record Key | b41f7264-87ba-49bc-a97f-cd6c9a0e036d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Celestial Star |
| Version Model Number | CS2050D-MRI |
| Catalog Number | CS2050D-MRI |
| Company DUNS | 073797367 |
| Company Name | Sunnex |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com | |
| Phone | +1(800)445-7869 |
| bill.long@sunnex.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853538008068 [Primary] |
FDA Product Code
| KZF | Device, medical examination, ac powered |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-02-26 |
On-Brand Devices [Celestial Star]
| 00853538008617 | CSLED-DLA29 |
| 00853538008600 | CS2050C-MRI-UK |
| 00853538008594 | CSLED-C39 |
| 00853538008532 | CSLED-W-AU |
| 00853538008211 | CSLED-D-HW |
| 00853538008204 | CSLED-W-HW |
| 00853538008198 | CSLED-C-HW |
| 00853538008181 | CSLED-CLA29 |
| 00853538008174 | CSLED-D |
| 00853538008167 | CSLED-C |
| 00853538008150 | CSLED-W |
| 00853538008143 | CSLED-M |
| 00853538008136 | CS2050W-UK |
| 00853538008129 | CS2050W-E |
| 00853538008112 | CS2050M-UK |
| 00853538008105 | CS2050M-MRI-UK |
| 00853538008099 | CS2050M-MRI-E |
| 00853538008082 | CS2050M-MRI |
| 00853538008075 | CS2050M-E |
| 00853538008068 | CS2050D-MRI |
| 00853538008051 | CS2050D-29LA |
| 00853538008044 | CS2050C-MRI |
| 00853538008037 | CS2050D |
| 00853538008020 | CS2050C |
| 00853538008013 | CS2050W |
| 00853538008006 | CS2050M |
| 00853538008648 | CS2050C-39 |
Trademark Results [Celestial Star]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELESTIAL STAR 79399782 not registered Live/Pending |
Lufthansa Technik Aktiengesellschaft 2024-04-10 |
 CELESTIAL STAR 78293700 2958394 Dead/Cancelled |
SEARS BRANDS, LLC 2003-08-28 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.