FDA.report

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
Rx
false
OTC
true
Sterile
true
Single use
false

Related Records

Product Codes

CodeName
FSQLight, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FSQLight, Surgical, InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08437016917176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08437016917176084370169171768437016917176

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

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
true
Expiration date on label
false
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 DIBrandModelCatalogPublished
08437016917015Rutilight power supplyFA-RL012025-01-31
08437016917282RutisideRS-012025-01-31

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08437016917015Rutilight power supplySWAN MEDICAL SL.FSQ2025-01-31
08437016917282RutisideSWAN MEDICAL SL.FSQ2025-01-31
00887761968554Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFSQ2023-07-11
00887761968509VidiaPortBaxter Medical Systems GmbH + Co. KGFSQ2023-01-17
00887761972841Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGFSQ2023-01-05
00887761968295iLED7 Surgical LightTRUMPF Medizin Systeme GmbH + Co. KGFSQ2023-01-05
00887761968387TL 5000/3000 – Surgical LightTRUMPF Medizin Systeme GmbH + Co. KGFSQ2023-01-04
00887761968301iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFSQ2022-12-15
00887761995635TruLightTRUMPF Medizin Systeme GmbH + Co. KGFSQ2016-09-17
00887761995642TruLightTRUMPF Medizin Systeme GmbH + Co. KGFSQ2016-09-17
00887761995659TruLightTRUMPF Medizin Systeme GmbH + Co. KGFSQ2016-09-17
00887761995666TruLightTRUMPF Medizin Systeme GmbH + Co. KGFSQ2016-09-17
00887761995673TruLightTRUMPF Medizin Systeme GmbH + Co. KGFSQ2016-09-17
00887761995680TruLightTRUMPF Medizin Systeme GmbH + Co. KGFSQ2016-09-17
00887761995697TruLightTRUMPF Medizin Systeme GmbH + Co. KGFSQ2016-09-17
00887761995710TruLightTRUMPF Medizin Systeme GmbH + Co. KGFSQ2016-09-17
00887761995871iLEDTRUMPF Medizin Systeme GmbH + Co. KGFSQ2016-09-17
00887761995918TruLightTRUMPF Medizin Systeme GmbH + Co. KGFSQ2016-09-17
00887761995949iLEDTRUMPF Medizin Systeme GmbH + Co. KGFSQ2016-09-17
00887761995963iLEDTRUMPF Medizin Systeme GmbH + Co. KGFSQ2016-09-17
10705034359014SPOTLIGHTDEPUY SPINE, LLCFSQ2016-06-30
10705034359045SPOTLIGHTDEPUY SPINE, LLCFSQ2016-06-30
10705034359076SPOTLIGHTDEPUY SPINE, LLCFSQ2016-06-30
10705034359137SPOTLIGHTDEPUY SPINE, LLCFSQ2016-06-30
10705034359328SPOTLIGHTDEPUY SPINE, LLCFSQ2016-06-30