FDA.reportPublic FDA data

Rutiside

Primary DI
08437016917404
Brand
Rutiside
Company
SWAN MEDICAL SL.
Model
RS-01
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
08437016917404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437016917404084370169174048437016917404

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 Temperature00

Regulatory Flags#

DUNS number
467190738
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
false
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
08437016917350RutilightRL-012026-09-04
08437016917015Rutilight power supplyFA-RL012025-01-31
08437016917176RutilightRL-012025-01-31
08437016917282RutisideRS-012025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437016917350RutilightSWAN MEDICAL SL.FSQ2026-09-04
07640177823816Neo Surgical LightsNeo Medical SAFSQ2026-07-10
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