FDA.reportPublic FDA data

Open Field Fluorescence Imaging Head

Primary DI
06973031299993
Brand
Open Field Fluorescence Imaging Head
Company
Guangdong Optomedic Technologies, Inc.
Model
OPTO-CHD3100H
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
IZISystem, X-Ray, Angiographic
OWNConfocal Optical Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
IZISystem, X-Ray, AngiographicRadiology2
OWNConfocal Optical ImagingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230407000FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.2023-07-17OWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973031299993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973031299993069730312999936973031299993

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

Regulatory Flags#

DUNS number
544527790
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973031299207InsufflatorOPTO-IFL10002026-04-22
069730312992833D Laparoscope21050SC2026-04-22
069730312992903D Laparoscope21050SA2026-04-22
06973031299931 FloNavi Endoscopic Camera HeadOPTO-CHD214KH2023-11-11
06973031299948 FloNavi Endoscopic Camera HeadOPTO-CHD214KE2023-11-10
069730312993373D Laparoscope21033SC2024-08-15
069730312993443D Laparoscope21033SA2024-08-15
06973031299375Stellar Light Source SL102024-08-15
06973031299382Stellar Exoscope31103FA2024-08-15
06973031299399Stellar 3D Fluorescence Camera HeadSC20D2024-08-15
06973031299405Stellar 3D Camera HeadSC10D2024-08-15
06973031299412Stellar Fluorescence Camera Head SC20E2024-08-15
06973031299429Stellar Camera HeadSC10E2024-08-15
06973031299436Stellar Image Processing UnitSI10E2024-08-15
06973031299504Stellar Light SourceSL202024-08-15
06973031299511 Image Processing Unit71-068-05 NIR-CA2024-04-22
06973031299528Light Source71-182-30 NIR-CA2024-04-22
06973031299535Endoscopic Fluorescence Camera Head71-068-20 NIR-CA2024-04-22
06973031299542Endoscopic Fluorescence Camera Head71-068-10 NIR-CA2024-04-22
06973031299825FloNavi Camera HeadOPTO-CHD21002024-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18
10850013527936DANNIKDannik LLCGCJ2026-08-17
108500135279817mm XL SUPERBAGDannik LLCGCJ2026-08-17
00889095731972ALVUEGLOBUS MEDICAL, INC.GCJ2026-08-14
00889095731989ALVUEGLOBUS MEDICAL, INC.GCJ2026-08-14
00190776423605MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776423650MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776423667MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776424510MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31