FDA.reportPublic FDA data

MIRA Minor Surgery Light

Primary DI
00667774000126
Brand
MIRA Minor Surgery Light
Company
Amico Lights Corporation
Model
MIRA
Catalog number
L-MLED65-CM-SC-ST
Device description
Mira LED 65, Ceiling Mount, Single, Standard Arm
Published
2017-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSYLight, Surgical, Ceiling Mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131893000AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.2013-10-30FSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00667774000126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00667774000126006677740001266677740001260667774000126

GMDN Terms#

Term, Definition table
TermDefinition
Fixed examination/treatment lightA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(905) 764-0800ekotyk@amico.com

Regulatory Flags#

DUNS number
203021407
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00667774000010MIRA Minor Surgery LightMIRAL-MLED50-CM-DC-EX2017-08-08
00667774000027MIRA Minor Surgery LightMIRAL-MLED50-CM-DC-ST2017-08-08
00667774000034MIRA Minor Surgery LightMIRAL-MLED50-CM-SC-EX2017-08-09
00667774000041MIRA Minor Surgery LightMIRAL-MLED50-CM-SC-ST2017-08-09
00667774000058MIRA Minor Surgery LightMIRAL-MLED50-FS-XX-EX2017-08-09
00667774000065MIRA Minor Surgery LightMIRAL-MLED50-FS-XX-ST2017-08-09
00667774000072MIRA Minor Surgery LightMIRAL-MLED50-WM-XX-EX2017-08-09
00667774000089MIRA Minor Surgery LightMIRAL-MLED50-WM-XX-ST2017-08-09
00667774000096MIRA Minor Surgery LightMIRAL-MLED65-CM-DC-EX2017-08-09
00667774000102MIRA Minor Surgery LightMIRAL-MLED65-CM-DC-ST2017-08-09
00667774000119MIRA Minor Surgery LightMIRAL-MLED65-CM-SC-EX2017-08-09
00667774000133MIRA Minor Surgery LightMIRAL-MLED65-FS-XX-EX2017-08-09
00667774000140MIRA Minor Surgery LightMIRAL-MLED65-FS-XX-ST2017-08-09
00667774000157MIRA Minor Surgery LightMIRAL-MLED65-WM-XX-EX2017-08-09
00667774000164MIRA Minor Surgery LightMIRAL-MLED65-WM-XX-ST2017-08-09
00667774000171MIRA Minor Surgery LightMIRAL-MLED90-CM-DC-EX2017-08-09
00667774000188MIRA Minor Surgery LightMIRAL-MLED90-CM-DC-ST2017-08-09
00667774000195MIRA Minor Surgery LightMIRAL-MLED90-CM-SC-EX2017-08-09
00667774000201MIRA Minor Surgery LightMIRAL-MLED90-CM-SC-ST2017-08-09
00667774000218MIRA Minor Surgery LightMIRAL-MLED90-FS-XX-EX2017-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251339907300YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907317YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907324YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907348YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907362YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907379YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
03700712436124VolistaMAQUET SASFSY2026-07-20
03700712436131VolistaMAQUET SASFSY2026-07-20
03700712436148VolistaMAQUET SASFSY2026-07-20
03700712436155VolistaMAQUET SASFSY2026-07-20
03700712436162VolistaMAQUET SASFSY2026-07-20
03700712436179VolistaMAQUET SASFSY2026-07-20
03700712436186VolistaMAQUET SASFSY2026-07-20
03700712436193VolistaMAQUET SASFSY2026-07-20
03700712436209VolistaMAQUET SASFSY2026-07-20
03700712436216VolistaMAQUET SASFSY2026-07-20
03700712436223VolistaMAQUET SASFSY2026-07-20
03700712436230VolistaMAQUET SASFSY2026-07-20
03700712436247VolistaMAQUET SASFSY2026-07-20
03700712436254VolistaMAQUET SASFSY2026-07-20
03700712436261VolistaMAQUET SASFSY2026-07-20
03700712436278VolistaMAQUET SASFSY2026-07-20
03700712436285VolistaMAQUET SASFSY2026-07-20
03700712436292VolistaMAQUET SASFSY2026-07-20
03700712436308VolistaMAQUET SASFSY2026-07-20
03700712436315VolistaMAQUET SASFSY2026-07-20
03700712436322VolistaMAQUET SASFSY2026-07-20
03700712436339VolistaMAQUET SASFSY2026-07-20
03700712436346VolistaMAQUET SASFSY2026-07-20
03700712436353VolistaMAQUET SASFSY2026-07-20