FDA.reportPublic FDA data

DPM, Endoscopic Fluorescence Camera System

Primary DI
06975689750482
Brand
DPM, Endoscopic Fluorescence Camera System
Company
Zhuhai Dipu Medical Technology Co., Ltd.
Model
DPM-ENDOSCOPE-0130
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
06975689750482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975689750482069756897504826975689750482

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical laparoscopeAn endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
704831914
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
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
06975689750093DPM, Endoscopic Fluorescence Camera SystemDPM-LIGHT-032024-09-05
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
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
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
08600105136202RE3Digital Surgery Systems, Inc.IZI2025-07-15
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
10193489068184NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068191NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068207NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068092MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10193489140170MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
10193489058826NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489058833NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059038NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059458NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
07613327502800PinpointSTRYKER CORPORATIONIZI2019-07-30
07613327502800PinpointSTRYKER CORPORATIONGCJ2019-07-30
08054890480055CLISIS SYSTEMSGENERAL MEDICAL MERATE SPAIZI2018-07-11
08054890480109Discovery RF180GENERAL MEDICAL MERATE SPAIZI2018-07-11
08806182216626LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182216657LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182210334LaportSejong Medical Co., LtdGCJ2018-04-05