Leo Minor LMI-700-EU
GUDID 00853538008624
Sunnex
Operating light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light Operating room light| Primary Device ID | 00853538008624 |
| NIH Device Record Key | e5161270-b1da-4a86-971f-c917f1e6b0aa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leo Minor |
| Version Model Number | LMI-700-EU |
| Catalog Number | LMI-700-EU |
| Company DUNS | 073797367 |
| Company Name | Sunnex |
| 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 | 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 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 |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853538008624 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142984
FDA Product Code
| FSY | Light, surgical, ceiling mounted |
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 | 2019-04-05 |
| Device Publish Date | 2019-03-28 |
On-Brand Devices [Leo Minor]
| 00853538008587 | LMI-550-AU |
| 00853538008570 | LMI-400-AU |
| 00853538008549 | LMI-400-UK |
| 00853538008396 | LMI-700 |
| 00853538008389 | LMI-550 |
| 00853538008372 | LMI-400 |
| 00853538008365 | LMI-300 |
| 00853538008624 | LMI-700-EU |
| 00853538008631 | LMI-700-AU |
Trademark Results [Leo Minor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEO MINOR 85820501 4561019 Live/Registered |
Sunnex 2013-01-10 |
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