FDA.reportPublic FDA data

Neo Surgical Lights

Primary DI
07640177823816
Brand
Neo Surgical Lights
Company
Neo Medical SA
Model
SL-20-00-FL
Device description
Neo Flex Light - 200 mm
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FSQLight, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSQLight, Surgical, InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640177823816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640177823816076401778238167640177823816

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
486778843
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640177820907Neo Medical Pedicle screw kitSI-MB-00-002026-07-10
07640177821393Neo Medical Pedicle screw kitSS-BS-00-NS2026-07-10
07640177821409Neo Medical Pedicle screw kitSS-CS-01-NS2026-07-10
07640177821416Neo Medical Pedicle screw kitSS-CS-02-NS2026-07-10
07640177823564Neo Medical RetractorsRP-00-40-002026-07-10
07640177823571Neo Medical RetractorsRP-00-50-002026-07-10
07640177823588Neo Medical RetractorsRP-00-60-002026-07-10
07640177823595Neo Medical RetractorsRP-00-70-002026-07-10
07640177823601Neo Medical RetractorsRP-00-80-002026-07-10
07640177823748Neo Medical RetractorsRP-00-40-BL2026-07-10
07640177823755Neo Medical RetractorsRP-00-50-BL2026-07-10
07640177823762Neo Medical RetractorsRP-00-60-BL2026-07-10
07640177823779Neo Medical RetractorsRP-00-70-BL2026-07-10
07640177823786Neo Medical RetractorsRP-00-80-BL2026-07-10
07640177823793Neo Medical RetractorsRP-00-90-BL2026-07-10
07640177823809Neo Medical RetractorsRP-00-AK-002026-07-10
07640177823007Neo Medical RetractorsRL-01-20-NS2024-02-06
07640177823021Neo Medical RetractorsRL-01-60-NS2024-02-06
07640177823038Neo Medical RetractorsRL-01-80-NS2024-02-06
07640177823045Neo Medical RetractorsRL-00-AK-NS2024-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437016917015Rutilight power supplySWAN MEDICAL SL.FSQ2025-01-31
08437016917176RutilightSWAN MEDICAL SL.FSQ2025-01-31
08437016917282RutisideSWAN MEDICAL SL.FSQ2025-01-31
00887761967250Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFSQ2023-07-11
00887761968554Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFSQ2023-07-11
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFSQ2023-06-26
00887761968479VidiaPortBaxter Medical Systems GmbH + Co. KGFSQ2023-01-17
00887761968486VidiaPortBaxter Medical Systems GmbH + Co. KGFSQ2023-01-17
00887761968493VidiaPortBaxter Medical Systems GmbH + Co. KGFSQ2023-01-17
00887761968509VidiaPortBaxter Medical Systems GmbH + Co. KGFSQ2023-01-17
00887761968325iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFSQ2023-01-05
00887761972841Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFSQ2023-01-05
00887761968288iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFSQ2023-01-05
00887761968295iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFSQ2023-01-05
00887761968394TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFSQ2023-01-05
00887761968400TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFSQ2023-01-05
00887761968448TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFSQ2023-01-05
00887761968387TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFSQ2023-01-04
00887761968417TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFSQ2023-01-04
00887761968127Pre-Install SetBaxter Medical Systems GmbH + Co. KGFSQ2022-12-15
00887761968134Pre-Install SetBaxter Medical Systems GmbH + Co. KGFSQ2022-12-15
00887761968271iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFSQ2022-12-15
00887761968301iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFSQ2022-12-15
00887761979840TRUMPF MEDICALBaxter Medical Systems GmbH + Co. KGFSQ2022-11-29
00887761980112TRUMPF MEDICALBaxter Medical Systems GmbH + Co. KGFSQ2022-11-29
00887761980129TRUMPF MEDICALBaxter Medical Systems GmbH + Co. KGFSQ2022-11-29
14589864500282OPELAIII Protected Special PackageTAIYO CORPORATIONFSQ2022-07-07
14589864500336OPELAIII COOLMAX® Comfort Inner PadsTAIYO CORPORATIONFSQ2022-07-07
14589864500350OPELAIII Attached Belt (3L)TAIYO CORPORATIONFSQ2022-07-07
00887761980174Hillrom™Baxter Medical Systems GmbH + Co. KGFSQ2021-07-06