FDA.reportPublic FDA data

Rutilight

Primary DI
08437016917176
Brand
Rutilight
Company
SWAN MEDICAL SL.
Model
RL-01
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
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
08437016917176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437016917176084370169171768437016917176

GMDN Terms#

Term, Definition table
TermDefinition
Open surgical site internal lightAn electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
467190738
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437016917015Rutilight power supplyFA-RL012025-01-31
08437016917282RutisideRS-012025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437016917015Rutilight power supplySWAN 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
00887761980181Hillrom™Baxter Medical Systems GmbH + Co. KGFSQ2021-07-06