FDA.reportPublic FDA data

HexaLux

Primary DI
10724995172500
Brand
HexaLux
Company
STERIS
Model
EXLHAN3
Catalog number
EXLHAN3
Device description
The HexaLux Sterilizable Light Handle is used with the HexaLux Exam Light.
Published
2020-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995172500PrimaryGS10
00724995172503Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499517250010724995172500
00724995172503007249951725037249951725030724995172503

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment handle cover, reusableA device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a rigid polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
569317142
Device count
3
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995169541NATable Pad S20CV3BF7692023-12-11
00724995169534NATable PadBF7682022-08-10
00724995230531NACassette TrayTAB7332025-01-31
00724995177782NATAB830HBF7902023-12-11
00724995177553NAORT501ORT5012023-11-22
00724995176822NAHEAD02HEAD022023-07-03
00724995176839NAHEAD04BHEAD04B2023-07-03
00724995178468NAH004WH004W2023-07-03
00724995178260NATAB800KTBF7892022-12-08
00724995177799NAClampBF7882022-08-10
00724995216825NACmax X-ray Imaging TableST01610002022-08-10
00724995216856NATAB830NABF7872022-08-10
00724995218355NACMAX XRAY JoystickBF7142022-08-10
00724995218362NACMAX XRAY Remote ControlBF7132022-08-10
00724995167790HexaLuxHexaLux Light Wall MountEXLWALL2020-06-30
00724995167806HexaLuxHexaLux Ceiling MountEXLCEIL2020-06-30
00724995167820HexaLuxHexaLux Light MobileEXLMBWB2020-06-30
00724995172459HexaLuxHexaLux Light MobileEXLMBWBUS2020-06-30
00724995172466HexaLuxHexaLux Light MobileEXLMNBHUS2020-06-30
00724995172473HexaLuxHexaLux Light Mobile StandEXLMWBHUS2020-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700393Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700416Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700423Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700843Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700850Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700874Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700881Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700997Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701017Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701031Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701048Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701062Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701086Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701093Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701109Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701116ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701123ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701130ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701147ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701154ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701161ArtiSential Precise DissectorLIVSMEDMDM2026-04-29