FDA.reportPublic FDA data

TRACLUX

Primary DI
M678TLC0
Brand
TRACLUX
Company
SUNOPTIC TECHNOLOGIES LLC
Model
TLC
Catalog number
TLC2575, TLC25150, TLC1353-U
Device description
TRACLUX Light Carrier, Sterile, Single Use, and accessories
Published
2021-11-05
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSZLight, Surgical, Carrier

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSZLight, Surgical, CarrierGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M678TLC1PackageHIBCC5In Commercial Distribution
M678TLC3PackageHIBCC20In Commercial Distribution
M678TLC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Open surgical site internal light sourceAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
904-773-7611Robert.Archie@sunoptictech.com

Regulatory Flags#

DUNS number
094586898
Device count
1
Premarket exempt
true
Lot or batch
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
M678SLSS0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerROVER SLSROVER SLS-S2023-03-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M678TLCSLS0TracLuxSUNOPTIC TECHNOLOGIES LLCFSZ2023-05-29
00816728020646PhotonGuideSTRYKER CORPORATIONFSZ2019-06-03
00816728020653PhotonGuideINVUITY, INC.FSZ2019-06-03
00816728021650PhotonGuideSTRYKER CORPORATIONFSZ2019-06-03
00816728020479PhotonGuide AdaptINVUITY, INC.FSZ2019-06-03
00816728021315PhotonGuide AdaptSTRYKER CORPORATIONFSZ2019-04-19
00643169857834N/AMEDTRONIC SOFAMOR DANEK, INC.FSZ2018-12-20
00816728020066PhotonGuideINVUITY, INC.FSZ2016-09-22
00816728020073PhotonGuideSTRYKER CORPORATIONFSZ2016-09-22
00816728020080PhotonGuideSTRYKER CORPORATIONFSZ2016-09-22
00816728020097PhotonGuideINVUITY, INC.FSZ2016-09-22