FDA.reportPublic FDA data

DPM, Endoscopic Fluorescence Camera System

Primary DI
06975689750093
Brand
DPM, Endoscopic Fluorescence Camera System
Company
Zhuhai Dipu Medical Technology Co., Ltd.
Model
DPM-LIGHT-03
Published
2024-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233840000Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.2024-06-26GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975689750093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975689750093069756897500936975689750093

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source unit, line-poweredA mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

Regulatory Flags#

DUNS number
704831914
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975689751052DPM, Endoscopic Fluorescence Camera System, 3D Endoscopic Fluorescence CamDPM-LIGHT-032024-09-20
06975689751069DPM, Endoscopic Fluorescence Camera System, 3D Endoscopic Fluorescence CamDPM-FB-012024-09-20
06975689750406DPM, 3D Endoscopic Fluorescence Camera SystemDPM-ENDOCAM-06PF2024-09-05
06975689750437DPM, Endoscopic Fluorescence Camera SystemDPM-ENDOCAM-03P-MF2024-09-05
06975689750444DPM, Endoscopic Fluorescence Camera SystemDPM-ENDOCAM-03P-CAM2024-09-05
06975689750451DPM, 3D Endoscopic Fluorescence Camera SystemDPM-ENDOCAM-06P-MF2024-09-05
06975689750475DPM, Endoscopic Fluorescence Camera SystemDPM-ENDOSCOPE-01002024-09-05
06975689750482DPM, Endoscopic Fluorescence Camera SystemDPM-ENDOSCOPE-01302024-09-05
06975689750659DPM, Endoscopic Fluorescence Camera SystemDPM-FB-012024-09-05
06975689750390DPM, Endoscopic Fluorescence Camera SystemDPM-ENDOCAM-03PF2024-09-02

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