FDA.reportPublic FDA data

iLED7 Surgical Light

Primary DI
00887761968325
Brand
iLED7 Surgical Light
Company
Baxter Medical Systems GmbH + Co. KG
Model
4068110
Device description
iLED 7 Ceiling Single
Published
2023-01-05
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
FSYLight, surgical, ceiling mounted
FTDLamp, surgical
KXJTable, radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQPLamp, Operating-RoomGeneral, Plastic Surgery2
FSQLight, Surgical, InstrumentGeneral, Plastic Surgery2
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2
FTDLamp, SurgicalGeneral, Plastic Surgery2
KXJTable, RadiologicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761968325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761968325008877619683258877619683250887761968325

GMDN Terms#

Term, Definition table
TermDefinition
Operating room 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
+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
04251339907300YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907317YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907324YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907348YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907362YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907379YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
03700712436124VolistaMAQUET SASFSY2026-07-20
03700712436131VolistaMAQUET SASFSY2026-07-20
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