Home GUDID 16971381250203 4K UHD Laparoscope
Primary DI 16971381250203
Brand 4K UHD Laparoscope
Company SCIVITA MEDICAL TECHNOLOGY CO., LTD.
Model 4K1030
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 16971381250203 Package GS1 2 In Commercial Distribution 06971381250206 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 16971381250203 16971381250203 06971381250206 06971381250206 6971381250206
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 Degrees Kelvin 106 Degrees Kelvin 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 00190776425883 Millennium Avalign Technologies, Inc. GCJ 2026-08-18 00190776425906 Millennium Avalign Technologies, Inc. GCJ 2026-08-18 00190776425968 Millennium Avalign Technologies, Inc. GCJ 2026-08-18 00190776425975 Millennium Avalign Technologies, Inc. GCJ 2026-08-18 00190776426361 Millennium Avalign Technologies, Inc. GCJ 2026-08-18 00190776426378 Millennium Avalign Technologies, Inc. GCJ 2026-08-18 10850013527936 DANNIK Dannik LLC GCJ 2026-08-17 10850013527981 7mm XL SUPERBAG Dannik LLC GCJ 2026-08-17 00889095731972 ALVUE GLOBUS MEDICAL, INC. GCJ 2026-08-14 00889095731989 ALVUE GLOBUS MEDICAL, INC. GCJ 2026-08-14 00190776423605 Millennium Avalign Technologies, Inc. GCJ 2026-08-07 00190776423650 Millennium Avalign Technologies, Inc. GCJ 2026-08-07 00190776423667 Millennium Avalign Technologies, Inc. GCJ 2026-08-07 00190776424510 Millennium Avalign Technologies, Inc. GCJ 2026-08-07 00190776422745 Millennium Avalign Technologies, Inc. GCJ 2026-08-03 00190776422752 Millennium Avalign Technologies, Inc. GCJ 2026-08-03 04026704934812 TELEFLEX TELEFLEX INCORPORATED GCJ 2026-08-03 B382SD4131490 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-03 B382SD4162910 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-03 B382SD49245120 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-03 B382SD55670280 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-03 B382SD56325330 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-03 B382SD56400150 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-03 B382SD56534210 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-03 B382SD567910130 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-03 B382SD56914330 Surgical Direct Surgical Direct, Inc. GCJ 2026-08-03 00190776421960 Millennium Avalign Technologies, Inc. GCJ 2026-07-31 00190776422325 Millennium Avalign Technologies, Inc. GCJ 2026-07-31 00888867498105 Arthrex® ARTHREX, INC. GCJ 2026-07-31 14026704921741 TELEFLEX TELEFLEX INCORPORATED GCJ 2026-07-31