FDA.reportPublic FDA data

ALYON

Primary DI
00724995223212
Brand
ALYON
Company
STERIS CORPORATION
Model
ALYON Surgical Lighting System
Catalog number
LYS15T
Device description
ALYON Triple Light, Tandem is used with the ALYON Lighting System
Published
2024-02-19
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995223212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995223212007249952232127249952232120724995223212

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
036985604
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403053924V. MuellerLA8506-45LA8506452016-09-24
00724995165307NAX-Ray Table TopBF6512021-04-02
10724995023833VERIFYDual SpeciesS3062016-09-09
10724995032798DARTNB113NB1132016-09-09
10724995154735VERIFY SIXCESSPCC072PCC0722019-04-19
10724995154742VERIFY SIXCESSPCC073PCC0732019-04-19
00724995000783Revital-Ox Resert4455N94455N92016-09-07
00724995095017Revital-Ox Resert4455AW4455AW2016-09-07
00724995153779AmscoWarming CabinetDJ060144123132020-06-11
00724995153816AmscoWarming CabinetDJ060144331112020-06-11
00724995161392HarmonyAIRM-Series SuspensionLM99APIT2020-06-17
00724995170493HarmonyAIRG-Series SuspensionLK00162020-05-19
00724995185886HarmonyAIRA-Series Suspension SystemLAS30NC012020-05-28
00724995185893HarmonyAIRA-Series Suspension SystemLAS30NC022020-05-28
00724995185909HarmonyAIRA-Series Suspension SystemLAS30NCND2020-05-28
00724995185916HarmonyAIRA-Series Suspension SystemLAS30NC01T2020-05-28
00724995185923HarmonyAIRA-Series Suspension SystemLAS30NC02T2020-05-28
00724995185930HarmonyAIRA-Series Suspension SystemLAS30NCNDT2020-05-28
00724995185947HarmonyAIRA-Series Suspension SystemLAS52NC012020-05-28
00724995185954HarmonyAIRA-Series Suspension SystemLAS52NC022020-05-28

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