FDA.reportPublic FDA data

AMTAI

Primary DI
00811889030886
Brand
AMTAI
Company
AMTAI MEDICAL EQUIPMENT, INC.
Model
LS3-BBA-1
Device description
Surgical Light, 2x625+LCD Spring Arm, 110V
Published
2018-07-06
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811889030886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811889030886008118890308868118890308860811889030886

GMDN Terms#

Term, Definition table
TermDefinition
Operating light systemAn assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830186198
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
00811889030749AMTAILS1-B-12018-07-06
00811889030756AMTAILS1-C-12018-07-06
00811889030763AMTAILS1-D-12018-07-06
00811889030770AMTAILS1-B-1(I)2018-07-06
00811889030787AMTAILS1-C-1(I)2018-07-06
00811889030794AMTAILS1-D-1(I)2018-07-06
00811889030800AMTAILS2-BB-12018-07-06
00811889030817AMTAILS2-BD-12018-07-06
00811889030824AMTAILS2-CB-12018-07-06
00811889030831AMTAILS2-CD-1 2018-07-06
00811889030848AMTAILS2-BB-1(I)2018-07-06
00811889030855AMTAILS2-BD-1(I)2018-07-06
00811889030862AMTAILS2-CB-1(I)2018-07-06
00811889030879AMTAILS2-CD-1(I) 2018-07-06
00811889030893AMTAILS3-BDA-12018-07-06
00811889030909AMTAILS3-CBA-1 2018-07-06
00811889030916AMTAILS3-CDA-1 2018-07-06
00811889030923AMTAILS3-BBA-1(I) 2018-07-06
00811889030930AMTAILS3-BDA-1(I) 2018-07-06
00811889030947AMTAILS3-CBA-1(I) 2018-07-06

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