FDA.reportPublic FDA data

Pre-Install Set

Primary DI
00887761968127
Brand
Pre-Install Set
Company
Baxter Medical Systems GmbH + Co. KG
Model
4068051
Device description
Pre-Install Set iLED 7
Published
2022-12-15
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761968127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761968127008877619681278877619681270887761968127

GMDN Terms#

Term, Definition table
TermDefinition
Medical device service railA device designed to provide a secure, rapid, and safe method of mounting and organizing medical and non-medical devices being used in the vicinity for patient treatment/care. It will typically be used in hospital wards, treatment rooms or an intensive care unit (ICU). It is usually fixed to a medical device service rail system, a medical device, or directly to a wall and in some cases it may be fixed to mobile devices. It will have a preformed cross-section incorporating a safety design compatible to the clamps expected to be mounted. It may be supplied in regular lengths which must be cut accordingly when fitted, or in prefabricated lengths.

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
10194665008857A-decA-DEC, INC.FTD2026-05-07
10192253051988DevonCardinal Health 200, LLCFSY2026-03-11
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
50192253021521DevonCardinal Health 200, LLCFSY2025-06-16
50192253053096DevonCardinal Health 200, LLCFSY2025-06-09
10192253052008DevonCardinal Health 200, LLCFSY2025-04-14
20192253051961DevonCardinal Health 200, LLCFSY2025-04-14
20192253051978DevonCardinal Health 200, LLCFSY2025-04-14
20192253051992DevonCardinal Health 200, LLCFSY2025-04-14
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FTD2024-02-22
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FTD2024-02-22
M678TLCSLS0TracLuxSUNOPTIC TECHNOLOGIES LLCFTD2023-05-29
08881300212001KLARO In Vivo Surgical LightingVIVO SURGICAL PRIVATE LIMITEDFTD2023-03-13
M678SLSS0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerSUNOPTIC TECHNOLOGIES LLCFTD2023-03-01
00684706007428iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007404iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00684706007411iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
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14589864500237OPELAIII Hard CaseTAIYO CORPORATIONFQP2021-04-07
14589864500275OPELAIII Protected Special PackageTAIYO CORPORATIONFSQ2021-04-07
14589864500275OPELAIII Protected Special PackageTAIYO CORPORATIONFQP2021-04-07
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