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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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