FDA.reportPublic FDA data

Sunoptic Technologies

Primary DI
M678CS0
Brand
Sunoptic Technologies
Company
SUNOPTIC TECHNOLOGIES LLC
Model
Camera System
Device description
camera systems
Published
2017-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWFCamera, Television, Endoscopic, Without Audio
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWFCamera, Television, Endoscopic, Without AudioGeneral, Plastic Surgery1
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M678CS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical video cameraAn electro-optical device (e.g., a CCD) designed to obtain moving-picture documentation of an open surgical procedure. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9047377611janice.lee@sunoptictech.com

Regulatory Flags#

DUNS number
094586898
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Donation ID number
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
M678HL0Sunoptic TechnologiesHeadlights2017-05-09
M678HLM0Sunoptic TechnologiesHeadlights Molded2017-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819761023094Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-04
05415334053168BarcoBarco NVKQM2026-06-02
05415334053335BarcoBarco NVKQM2026-06-02
05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
03700712434472Maquet OrchideMAQUET SASKQM2026-05-06
03700712434489Maquet OrchideMAQUET SASKQM2026-05-06
00840319757987Hayden MedicalHayden Medical, Inc.FWF2026-04-23
00840319758984Hayden MedicalHayden Medical, Inc.FWF2026-04-22
00840319758991Hayden MedicalHayden Medical, Inc.FWF2026-04-22
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
08051887043286THD DIGITAL MINICAMTHD SPAFWF2025-02-20
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15
14714127861392AESCULAPAesculap AGKQM2023-11-05
00887761967267Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGKQM2023-07-11
30845854050730CONMEDConmed CorporationKQM2023-06-16
10618125131041DEXcam3™ Intra-oral Camera SheathsTIDI PRODUCTS, LLCKQM2023-04-13
10618125155870DEXcam4™ Intra-oral Camera SheathsTIDI PRODUCTS, LLCKQM2023-04-13
04250337100317C-Camsource®Joimax GmbHFWF2022-12-30
04250337100324C-Camsource®Joimax GmbHFWF2022-12-30
04250337100331C-Camsource®Joimax GmbHFWF2022-12-30