FDA.reportPublic FDA data

Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer

Primary DI
M678SLSS0
Brand
Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer
Company
SUNOPTIC TECHNOLOGIES LLC
Model
ROVER SLS
Catalog number
ROVER SLS-S
Device description
Battery powered light source for illumination of a surgical field.
Published
2023-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCWLight Source, Fiberoptic, Routine
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCWLight Source, Fiberoptic, RoutineGastroenterology, Urology2
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M678SLSS1PackageHIBCC5In Commercial Distribution
M678SLSS3PackageHIBCC20In Commercial Distribution
M678SLSS0PrimaryHIBCC0

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
Special Storage Condition, Specify00Device should be stored in cool dry location

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
094586898
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M678HLC0Sunoptic TechnologiesHeadlight Cables2017-05-09
M678FOC0Sunoptic TechnologiesFiberoptic Cables2017-05-09
M678TLCSLS0TracLuxTracLux-SLSTLC1353-SLSU2023-05-29
M678TX0Sunoptic Technologies Tx series Xenon Lightsource2017-05-09
M678DPLS300W0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerDPLS-01, DPLS-032022-02-25
00855373008036NICO Myriad-LXTx350ANN-70642025-06-03
00855373008043NICO Corporation STX0350NN-90102025-06-03
00855373008029StrykerLLS-050INV-LLS-2000HPAK2025-05-15
M678TLS0TracLuxTLS2575, TLS25150TLS2550, TLS251502025-05-08
M678NN70640NICO Myriad-LXTX350ANN-70642025-03-27
M678NN90100NICONN-9010NN-90102025-03-27
M678SLS0Sunoptic TechnologiesRover Lightsource series2018-06-27
M678HHR0TRACLUXHHRTLH001, TLH002, TLB2575, TLB251502021-11-05
M678DLS0Sunoptic TechnologiesRover Lightsource series2018-06-27
M678DLS10Sunoptic TechnologiesRover Lightsource series2018-06-27
M678ROVER0Sunoptic TechnologiesRover Lightsource series2017-05-09
M678SLS10Sunoptic TechnologiesRover Lightsource series2018-06-27
M678CS0Sunoptic TechnologiesCamera System2017-05-09
M678HL0Sunoptic TechnologiesHeadlights2017-05-09
M678HLM0Sunoptic TechnologiesHeadlights Molded2017-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194665008857A-decA-DEC, INC.FTD2026-05-07
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
00850036790013AveliRevelle Aesthetics, Inc.FTD2024-02-26
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FTD2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FTD2024-02-22
03700712432423Maquet EzeaMAQUET SASFTD2024-01-10
00887761967250Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFTD2023-07-11
03700712430597Maquet PowerLED IIMAQUET SASFTD2023-07-05
00887761967274Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGFTD2023-06-26
M678TLCSLS0TracLuxSUNOPTIC TECHNOLOGIES LLCFTD2023-05-29
00816744027643NICO Myriad-LXNICO CORPORATIONFTD2023-04-26
08881300212001KLARO In Vivo Surgical LightingVIVO SURGICAL PRIVATE LIMITEDFTD2023-03-13
00887761968493VidiaPortBaxter Medical Systems GmbH + Co. KGFTD2023-01-17
00887761968325iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2023-01-05
00887761968295iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2023-01-05
00887761968394TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2023-01-05
00887761968448TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2023-01-05
00887761968387TL 5000/3000 – Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2023-01-04
00887761968127Pre-Install SetBaxter Medical Systems GmbH + Co. KGFTD2022-12-15
00887761968271iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2022-12-15
00887761968301iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGFTD2022-12-15
00887761979840TRUMPF MEDICALBaxter Medical Systems GmbH + Co. KGFTD2022-11-29
00887761980112TRUMPF MEDICALBaxter Medical Systems GmbH + Co. KGFTD2022-11-29
00887761980129TRUMPF MEDICALBaxter Medical Systems GmbH + Co. KGFTD2022-11-29
00850036790006AveliRevelle Aesthetics, Inc.FTD2022-02-14
00887761980181Hillrom™Baxter Medical Systems GmbH + Co. KGFTD2021-07-06
00887761980204Hillrom™Baxter Medical Systems GmbH + Co. KGFTD2021-07-06
00887761986060Hillrom™Baxter Medical Systems GmbH + Co. KGFTD2021-07-06
10840143902017DissectorATRICURE, INC.FTD2021-01-11
10840143902130DissectorATRICURE, INC.FTD2021-01-11