Home GUDID 16971381250180 4K UHD Laparoscope
Primary DI 16971381250180
Brand 4K UHD Laparoscope
Company SCIVITA MEDICAL TECHNOLOGY CO., LTD.
Model 4K5545
Device description These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.
Published 2023-05-17
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GCJ Laparoscope, General & Plastic Surgery HET Laparoscope, Gynecologic (And Accessories)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology 2 HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 16971381250180 Package GS1 2 In Commercial Distribution 06971381250183 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 16971381250180 16971381250180 06971381250183 06971381250183 6971381250183
GMDN Terms# Term, Definition table Term Definition Rigid optical laparoscope An 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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Handling Environment Temperature 5 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 20 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity -40 Degrees Celsius 55 Degrees Celsius
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization Moist Heat or Steam Sterilization;Hydrogen Peroxide Moist Heat or Steam Sterilization;Hydrogen Peroxide;High-level Disinfectant
Regulatory Flags# DUNS number 544519831 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00198506044366 ELMED ELMED INCORPORATED GCJ 2026-06-09 00812231033906 Pixa SANTA BARBARA IMAGING SYSTEMS, INC. GCJ 2026-06-08 00812231033913 Pixa SANTA BARBARA IMAGING SYSTEMS, INC. GCJ 2026-06-08 00812231033920 Pixa SANTA BARBARA IMAGING SYSTEMS, INC. GCJ 2026-06-08 00812231034095 Pixa SANTA BARBARA IMAGING SYSTEMS, INC. GCJ 2026-06-08 00812231034101 Pixa SANTA BARBARA IMAGING SYSTEMS, INC. GCJ 2026-06-08 04717480900336 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900343 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900350 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900367 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900398 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900404 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900763 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900770 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900787 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 04717480900800 Inno-Port TAIWAN SURGICAL CORPORATION GCJ 2026-06-08 E496C05HPDH0 Handle for pneumodissection Hook AB MEDICA GCJ 2026-06-08 E496C05IDCH20ST1 Hook insert and tube for pneumodissection D=5,0mm Lg=20cm, sterile single use AB MEDICA GCJ 2026-06-08 E496C05IDCH33ST1 Hook insert and tube for pneumodissection D=5,0mm Lg=33cm, sterile single use AB MEDICA GCJ 2026-06-08 E496C35IDCH20ST1 Hook insert and tube for pneumodissection D=3,5mm Lg=20cm, sterile single use AB MEDICA GCJ 2026-06-08 E496C35IDCH33ST1 Hook insert and tube for pneumodissection D=3,5mm Lg=33cm, sterile single use AB MEDICA GCJ 2026-06-08 00198506091414 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-06-05 00198506091421 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-06-05 00198506091438 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-06-05 00198506091452 ELMED INCORPORATED ELMED INCORPORATED HET 2026-06-05 00198506091469 ELMED INCORPORATED ELMED INCORPORATED HET 2026-06-05 00817401029161 Endoplus Endoplus HET 2026-06-05 00198506091247 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-06-03 00198506091254 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-06-03 00192896123427 Trocar SONTEC INSTRUMENTS, INC. GCJ 2026-06-02