FDA.reportPublic FDA data

SurgiLux™

Primary DI
M710SL120
Brand
SurgiLux™
Company
BIOTEX, INC.
Model
SL-12
Catalog number
SL-12
Published
2019-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M710SL122PackageHIBCC12In Commercial Distribution
M710SL124PackageHIBCC48In Commercial Distribution
M710SL120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Operating room 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity25 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
7137410111xx@xx.xx

Regulatory Flags#

DUNS number
969792050
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M710TCW51000Bayou™ troCarWash System Disposable KitTCW-5-1002025-10-10
M710TCW101200Bayou™ troCarWash System Disposable KitTCW-10-1202024-01-31
M71004614002Slide Bite Fork046-1400046-14002025-02-28
M710NDK2Safe-Cam Tablet and Accessories033-5000SC-NDK2018-07-25
M710SCC0Safe-Cam Connecting Cable Assembly033-6500SC-C2018-07-25
M710SCM0Safe-Cam Display Monitor Assembly033-6501SC-M2018-07-25
M710SCMR0Safe-Cam Display Monitor Charger033-6000-003SC-MR2018-07-25
M710SCVS0Safe-Cam Sterile Video Stylet033-1000SC-VS2018-07-25
M710TCWC0Bayou™ troCarWash System ControllerTCW-C2024-01-22
M710WW1D0Wire Watch™WW-1D2024-07-03
M710ERGUIDE10050OcciGuide048-1001ER GUIDE 10052021-02-25
M710ERGUIDE10100OcciGuide048-1000ER GUIDE 10102021-02-25
M710ERGUIDE1010OcciGuideER GUIDE 1010048-10002020-02-20
M71003810000Bayou™ troCarWash System Disposable Kit038-10002023-08-04
M71003850000Bayou™ troCarWash System Controller038-50002023-08-04
M710WW12K0Wire Watch™WW-12K2023-07-31
M71002110010Wire Watch™021-10012023-02-09
M71004615000The Slide®046-15002023-05-19
M71004610000The Slide®046-10002021-09-01
M710ERGUIDE10102OcciGuide048-1000ER GUIDE 10102021-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194665008857A-decA-DEC, INC.FTD2026-05-07
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
04048675754947PolarisDrägerwerk AG & Co. KGaAFTD2025-11-05
03700712434526Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712435851Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436063Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436087Maquet PowerLED IIMAQUET SASFTD2025-09-03
00850036790020AliteRevelle Aesthetics, Inc.FTD2025-09-01
00816744027230Myriad-LXNICO CORPORATIONFTD2025-08-11
00860013851576Nova 3QED, INC.FTD2025-05-22
00860013851507BeamerQED, INC.FTD2025-05-21
00860013851514Nova 300QED, INC.FTD2025-05-21
08800053093767S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093774S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093781S300 Series DENTIS CO. ,LTDFTD2025-02-19
08800053093798S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093804S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093828S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093835S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093842S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093859S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093866S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093873S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093880S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093897S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093903S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093910S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093927S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093941S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093958S300 SeriesDENTIS CO. ,LTDFTD2025-02-19