FDA.reportPublic FDA data

TruLight

Primary DI
00887761995710
Brand
TruLight
Company
Baxter Medical Systems GmbH + Co. KG
Model
4038130
Device description
Hospital Device
Published
2016-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQPLamp, operating-room
FSQLight, surgical, instrument
FTDLamp, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQPLamp, Operating-RoomGeneral, Plastic Surgery2
FSQLight, Surgical, InstrumentGeneral, Plastic Surgery2
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761995710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761995710008877619957108877619957100887761995710

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

Contacts#

Phone, Email table
PhoneEmail
+49367158641911service.wwo@trumpfmedical.com

Regulatory Flags#

DUNS number
330961223
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
00887761968479VidiaPort40281552023-01-17
00887761968486VidiaPort40281522023-01-17
00887761968493VidiaPort40281502023-01-17
00887761968509VidiaPort40281402023-01-17
00887761968516VidiaPort40281302023-01-17
00887761979840TRUMPF MEDICAL40281522022-11-29
00887761980105TRUMPF MEDICAL40281402022-11-29
00887761980112TRUMPF MEDICAL40281502022-11-29
00887761980129TRUMPF MEDICAL40281552022-11-29
00887761970007Leg Sections20778652022-12-14
00887761970045Head Sections20778602022-12-14
00887761970052Back Sections20775952022-12-14
00887761970144Pelvis Sections20726292022-12-15
00887761970151Leg Sections20726282022-12-15
00887761970168Leg Sections20726262022-12-15
00887761970175Leg Sections20726252022-12-14
00887761970182Back Sections20726242022-12-14
00887761970199Head Sections20726232022-12-14
00887761970014Leg Sections20778642022-12-14
00887761970069Back Sections20775942022-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437016917350RutilightSWAN MEDICAL SL.FSQ2026-09-04
08437016917404RutisideSWAN MEDICAL SL.FSQ2026-09-04
10850009233049BihlerMedBihlerMed, L.L.C.FTD2026-07-24
10850009233056BihlerMedBihlerMed, L.L.C.FTD2026-07-24
06972545090331JeashiaZhejiang Honsun Medical Technology Co., Ltd.FQP2026-07-17
16972545090079JeashiaZhejiang Honsun Medical Technology Co., Ltd.FQP2026-07-17
07640177823816Neo Surgical LightsNeo Medical SAFSQ2026-07-10
10194665008857A-decA-DEC, INC.FTD2026-05-07
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
00850036790013AveliRevelle Aesthetics, Inc.FTD2024-02-26
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FTD2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FTD2024-02-22
00887761967250Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFSQ2023-07-11
00887761967250Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFTD2023-07-11
00887761967250Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-07-11
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFTD2023-06-26
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFSQ2023-06-26
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-06-26
M678TLCSLS0TracLuxSUNOPTIC TECHNOLOGIES LLCFTD2023-05-29
00816744027643NICO Myriad-LXNICO CORPORATIONFTD2023-04-26
08881300212001KLARO In Vivo Surgical LightingVIVO SURGICAL PRIVATE LIMITEDFTD2023-03-13
M678SLSS0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerSUNOPTIC TECHNOLOGIES LLCFTD2023-03-01
00887761968479VidiaPortBaxter Medical Systems GmbH + Co. KGFSQ2023-01-17
00887761968479VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968486VidiaPortBaxter Medical Systems GmbH + Co. KGFSQ2023-01-17
00887761968486VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968493VidiaPortBaxter Medical Systems GmbH + Co. KGFSQ2023-01-17
00887761968493VidiaPortBaxter Medical Systems GmbH + Co. KGFTD2023-01-17
00887761968325iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFSQ2023-01-05
00887761968325iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2023-01-05