FDA.reportPublic FDA data

Helux Pro Surgical Light

Primary DI
00887761976474
Brand
Helux Pro Surgical Light
Company
Baxter Medical Systems GmbH + Co. KG
Model
4108120
Device description
Helux Pro Mobile
Published
2023-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQPLamp, operating-room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQPLamp, Operating-RoomGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761976474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761976474008877619764748877619764740887761976474

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4936715860SURGICAL@HILLROM.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
00887761967250Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-07-11
00887761968547Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-07-11
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFQP2023-06-26
06974539960002SAIKANGJiangsu Saikang Medical Equipment Co.,Ltd.FQP2023-05-31
00887761976450Pre-Install Set Helux ProBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977334Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977341Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977358Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977365Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761977389Helux Pro Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-03-07
00887761968479VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968486VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968493VidiaPortBaxter Medical Systems GmbH + Co. KGFQP2023-01-17
00887761968325iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761970939Carbon SectionsBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972872Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972889Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761974432Control UnitsBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968288iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968295iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968394TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968400TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968448TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972902Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972926Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761972957Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFQP2023-01-05
00887761968387TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-04
00887761968417TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFQP2023-01-04
00887761968127Pre-Install SetBaxter Medical Systems GmbH + Co. KGFQP2022-12-15
00887761968134Pre-Install SetBaxter Medical Systems GmbH + Co. KGFQP2022-12-15