FDA.reportPublic FDA data

MIRA Minor Surgery Light

Primary DI
00667774000218
Brand
MIRA Minor Surgery Light
Company
Amico Lights Corporation
Model
MIRA
Catalog number
L-MLED90-FS-XX-EX
Device description
Mira LED 90, Floorstand, Extended 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
00667774000218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00667774000218006677740002186677740002180667774000218

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
00667774000126MIRA Minor Surgery LightMIRAL-MLED65-CM-SC-ST2017-08-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00684706009842iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-16
00684706009859iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-16
00684706009835iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-06
10192253051988DevonCardinal Health 200, LLCFSY2026-03-11
00684706009804iCE Surgical LightAmico Clinical Solutions CorpFSY2025-10-09
50192253021521DevonCardinal Health 200, LLCFSY2025-06-16
50192253053096DevonCardinal Health 200, LLCFSY2025-06-09
10192253052008DevonCardinal Health 200, LLCFSY2025-04-14
20192253051961DevonCardinal Health 200, LLCFSY2025-04-14
20192253051978DevonCardinal Health 200, LLCFSY2025-04-14
20192253051992DevonCardinal Health 200, LLCFSY2025-04-14
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
00684706007442iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007459iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007466iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007473iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007480iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007497iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007428iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007435iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007404iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00684706007411iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00724995199364HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199388HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199395HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199401HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199425HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199432HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199456HarmonyAIRSTERIS CORPORATIONFSY2021-04-09