FDA.reportPublic FDA data

Leo Minor

Primary DI
00853538008372
Brand
Leo Minor
Company
Sunnex
Model
LMI-400
Catalog number
LMI-400
Published
2018-02-26
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
K142984000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142984000Leo MinorSunnex, Inc.2014-10-29FSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853538008372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853538008372008535380083728535380083720853538008372

GMDN Terms#

Term, Definition table
TermDefinition
Operating lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)445-7869bill.long@sunnex.com

Regulatory Flags#

DUNS number
073797367
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853538008631Leo MinorLMI-700-AULMI-700-AU2021-12-09
00853538008648Celestial StarCS2050C-39CS2050C-392021-12-09
00853538008617Celestial StarCSLED-DLA29CSLED-DLA292019-01-24
00853538008624Leo MinorLMI-700-EULMI-700-EU2019-03-28
00853538008006Celestial StarCS2050MCS2050M2018-02-26
00853538008013Celestial StarCS2050WCS2050W2018-02-26
00853538008020Celestial StarCS2050CCS2050C2018-02-26
00853538008037Celestial StarCS2050DCS2050D2018-02-26
00853538008044Celestial StarCS2050C-MRICS2050C-MRI2018-02-26
00853538008051Celestial StarCS2050D-29LACS2050D-29LA2018-02-26
00853538008068Celestial StarCS2050D-MRICS2050D-MRI2018-02-26
00853538008075Celestial StarCS2050M-ECS2050M-E2018-02-26
00853538008082Celestial StarCS2050M-MRICS2050M-MRI2018-02-26
00853538008099Celestial StarCS2050M-MRI-ECS2050M-MRI-E2018-02-26
00853538008105Celestial StarCS2050M-MRI-UKCS2050M-MRI-UK2018-02-26
00853538008112Celestial StarCS2050M-UKCS2050M-UK2018-02-26
00853538008129Celestial StarCS2050W-ECS2050W-E2018-02-26
00853538008136Celestial StarCS2050W-UKCS2050W-UK2018-02-26
00853538008143Celestial StarCSLED-MCSLED-M2018-02-26
00853538008150Celestial StarCSLED-WCSLED-W2018-02-26

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