FDA.reportPublic FDA data

Pharos HD CCU

Primary DI
00851610007336
Brand
Pharos HD CCU
Company
LONG ISLAND TECH
Model
P003505
Device description
Surgical Camera & Light
Published
2021-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851610007336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851610007336008516100073368516100073360851610007336

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity45 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature60 Degrees Fahrenheit80 Degrees Fahrenheit
Storage Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
030256600
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851610007251BayPort Storage SolutionP0036002020-11-02
00851610007091AtoN Keywest Headlight without Fiber Optic CableP0032672016-09-02
00851610007107HatterasP0027002016-09-02
00851610007114AtoN Optic OnlyP0032482016-09-02
00851610007121AtoN Classic Headlight without Fiber Optic CableP0032652016-09-02
00851610007138AtoN Classic Headlight with Cobra Fiber Optic CableP0032492016-09-02
00851610007145AtoN Classic Headlight with 10' Fiber Optic CableP0032552016-09-02
00851610007152AtoN Keywest Headlight with Cobra Fiber Optic CableP0032502016-09-02
00851610007169AtoN Keywest Headlight with 10' Fiber Optic CableP0032572016-09-02
00851610007176AtoN Keywest Headlight with 7' Fiber Optic CableP0032622016-09-02
00851610007183AtoN Classic Headlight with 7' Fiber Optic CableP0032602016-09-09
00851610007220Pharos HD HeadcamP0034052021-06-07
00851610007299Fiji HeadbandP0078092021-06-07
00851610007190Dover Headlight OpticP0025052020-12-21
00851610007206Bristol Headlight OpticP0026052020-12-21
00851610007213Daymark Headlight OpticP0031002020-12-21
00851610007268Dover HolsterP0025502020-12-21
00851610007275Bristol HolsterP0025502020-12-21
00851610007282Daymark HolsterP0031502020-12-21
00851610007244BayPort 6-Bay ChargerP0037002020-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819761023063Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-05
00819761023087Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-05
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
04548736183407SONYSONY CORPORATIONKQM2026-04-30
04548736183414SONYSONY CORPORATIONKQM2026-04-30
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
04548736155978SONYSONY CORPORATIONKQM2025-11-04
04548736155985SONYSONY CORPORATIONKQM2025-11-04
04548736169968SONYSONY CORPORATIONKQM2025-11-04
04548736169951SONYSONY CORPORATIONKQM2025-10-06
04548736155091SONYSONY CORPORATIONKQM2025-09-30
04548736155107SONYSONY CORPORATIONKQM2025-09-30
04548736170735SONYSONY CORPORATIONKQM2025-09-30
04548736170759SONYSONY CORPORATIONKQM2025-09-30
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170681SONYSONY CORPORATIONKQM2025-06-24
04548736170704SONYSONY CORPORATIONKQM2025-06-24
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09