FDA.reportPublic FDA data

AMTAI

Primary DI
00811889031289
Brand
AMTAI
Company
AMTAI MEDICAL EQUIPMENT, INC.
Model
LM-B-1
Device description
Mobile Surgical Light, 625, 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
FSSLight, Surgical, Floor Standing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSSLight, Surgical, Floor StandingGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811889031289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811889031289008118890312898118890312890811889031289

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.

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
00811889030886AMTAILS3-BBA-1 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855373008036NICO Myriad-LXSUNOPTIC TECHNOLOGIES LLCFSS2025-06-03
00855373008043NICO Corporation SUNOPTIC TECHNOLOGIES LLCFSS2025-06-03
M678NN70640NICO Myriad-LXSUNOPTIC TECHNOLOGIES LLCFSS2025-03-27
M678NN90100NICOSUNOPTIC TECHNOLOGIES LLCFSS2025-03-27
10686864056819Medicom SafeMaskAMD Medicom IncFSS2025-01-23
20686864056816Medicom SafeMaskAMD Medicom IncFSS2025-01-23
03700712412029Maquet RoliteMAQUET SASFSS2024-11-07
04250613849282DM MS Sim.LED ExL DES.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849305MS Sim.LED OpL wSBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849329MS Sim.LED OpL wDBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849367MS Sim.LED OpL USS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849404DM MS Sim.LED ExL wSBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
03700712432508Maquet RoliteMAQUET SASFSS2024-06-20
03700712432522Maquet RoliteMAQUET SASFSS2024-06-20
03700712432515Maquet RoliteMAQUET SASFSS2024-02-02
14026704741837PILLINGTELEFLEX INCORPORATEDFSS2024-01-16
24026704741834PILLINGTELEFLEX INCORPORATEDFSS2024-01-16
03700712432539Maquet RoliteMAQUET SASFSS2023-12-15
03700712422745Maquet RoliteMAQUET SASFSS2023-09-19
03700712422752Maquet RoliteMAQUET SASFSS2023-09-19
03700712422769Maquet RoliteMAQUET SASFSS2023-09-19
03700712422776Maquet RoliteMAQUET SASFSS2023-09-19
03700712422783Maquet RoliteMAQUET SASFSS2023-09-19
03700712422790Maquet RoliteMAQUET SASFSS2023-09-19
03700712422806Maquet RoliteMAQUET SASFSS2023-09-19
03700712422813Maquet RoliteMAQUET SASFSS2023-09-19
03700712422820Maquet RoliteMAQUET SASFSS2023-09-19
03700712422837Maquet RoliteMAQUET SASFSS2023-09-19
03700712422844Maquet RoliteMAQUET SASFSS2023-09-19
03700712422851Maquet RoliteMAQUET SASFSS2023-09-19