FDA.reportPublic FDA data

MI Product Line

Primary DI
00816835020751
Brand
MI Product Line
Company
Medical Illumination International Inc.
Model
061422-V
Device description
MI-750 Minor Surgical Light, Wall Mount
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K140812000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140812000MI-750 PROCEDURAL/MINOR SURGICAL LIGHTMedical Illumination International, Inc.2014-08-07FSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01816835020750PackageGS11In Commercial Distribution
00816835020751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01816835020750018168350207501816835020750
00816835020751008168350207518168350207510816835020751

GMDN Terms#

Term, Definition table
TermDefinition
Medical monitor/light mountA permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093357739
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816835024384SYSTEM TWO LEDSD3CD3-CNE-LCH-4K2026-04-30
00816835024391SYSTEM TWO LEDSD3CD3-CNE-4K2026-04-30
00816835024407SYSTEM TWO LEDSD2CD2M1-LCH-4K2026-04-30
00816835024414SYSTEM TWO LEDSD3CDEM1-CNE-4K2026-04-30
00816835024421SYSTEM TWO LEDSD2C-LCH-4K2026-04-30
00816835024438SYSTEM TWO LEDSD3CD3M1M1-LCH-4K2026-04-30
00816835024445SYSTEM TWO LEDSD2CD2-4K2026-04-30
00816835024452SYSTEM TWO LEDSD2CD2-LCH-4K2026-04-30
00816835024469SYSTEM TWO LEDSD2CM1-LCH-4K2026-04-30
00816835024476SYSTEM TWO LEDSD3C-CNE-4K2026-04-30
00816835024483SYSTEM TWO LEDSD3CM1-CNE-LCH-4K2026-04-30
00816835023813VIDASHIELD/UV24071214/VS02D2022-12-16
01816835023812VIDASHIELD/UV24071214/VS02D2022-12-16
00816835024360Vu160NVSD3D3M1-LCH2025-02-19
00816835024353Vu160NVSD3M1-LCH2025-02-19
01816835024369Vu160NVSD3D3M1-LCH2025-02-19
00816835020409Vistor PRO LEDNV061513B2016-09-23
00816835024346SM1SM12024-09-04
01816835024345SM1SM12024-09-04
00816835024322MI-1000CAM061524CAM2024-08-19

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