DEVICE: MIRA Minor Surgery Light (00667774000232)
Device Identifier (DI) Information
MIRA Minor Surgery Light
MIRA
In Commercial Distribution
L-MLED90-WM-XX-EX
Amico Lights Corporation
MIRA
In Commercial Distribution
L-MLED90-WM-XX-EX
Amico Lights Corporation
Mira LED 90, Wall Mount, Extended Arm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
12276 | Fixed examination/treatment room light |
A fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FSY | Light, Surgical, Ceiling Mounted |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K131893 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f054e0b2-5b69-4cd3-8aaf-4b14b649d515
January 08, 2021
4
August 09, 2017
January 08, 2021
4
August 09, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(905) 764-0800
ekotyk@amico.com
ekotyk@amico.com