FDA.reportPublic FDA data

Leo Minor

Primary DI
00853538008624
Brand
Leo Minor
Company
Sunnex
Model
LMI-700-EU
Catalog number
LMI-700-EU
Published
2019-03-28
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
00853538008624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853538008624008535380086248535380086240853538008624

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
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
00853538008167Celestial StarCSLED-CCSLED-C2018-02-26

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