FDA.reportPublic FDA data

TL 5000/3000 – Surgical Light

Primary DI
00887761968424
Brand
TL 5000/3000 – Surgical Light
Company
Baxter Medical Systems GmbH + Co. KG
Model
4038130
Device description
TruLight 5000 / 3000 Wall
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
IWYHolder, head, radiographic
JEATABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
KXJTable, radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1
JEATable, Surgical With Orthopedic Accessories, Ac-PoweredGeneral, Plastic Surgery1
KXJTable, RadiologicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761968424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761968424008877619684248877619684240887761968424

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
00198953081839NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953081877NAGE Medical Systems, L.L.C.KXJ2026-04-02
00198953089835NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00198953089842NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDKXJ2026-04-02
00842430116735ADANTE ADAPTER, MAI CLARK SOCKETMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2026-03-31
00842430116766 WELL LEG SUPPORT, SHORTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2026-03-31
00840343726720FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726737FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726744FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726751FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726768FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726775FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00842430109294ADANTE SADDLE POSTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109300ADANTE EXTENDED SADDLE POSTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109317ADANTE TRACTION BOOT, SMALL, PAIRMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109324ADANTE TRACTION BOOT, LARGE, PAIRMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109331ADANTE TRACTION BOOT, EX LARGE, PAIRMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430116605Adante Femoral Hook BracketMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430116612Adante Knee Foot SupportMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117008Adante IntelliTouch Hand PendantMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117022Adante Traction Mount, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117039Adante Traction Mount, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117046Adante Pelvic Center BoardMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117053Adante Knee Extension BoardMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117084Adante Knee Mount, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117091Adante Knee Mount, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117107Adante FlexLation Spar, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117114Adante FlexLation Spar, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117121Adante AX Orthopedic Surgical PlatformMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117138Adante Knee Pad Support Mount, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04