Home GUDID 16971381250197 4K UHD Laparoscope
Primary DI 16971381250197
Brand 4K UHD Laparoscope
Company SCIVITA MEDICAL TECHNOLOGY CO., LTD.
Model 4K1000
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 16971381250197 Package GS1 2 In Commercial Distribution 06971381250190 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 16971381250197 16971381250197 06971381250190 06971381250190 6971381250190
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 5 Degrees Celsius 40 Degrees Celsius Handling Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 20 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -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 00190776422110 Millennium Avalign Technologies, Inc. GCJ 2026-07-24 00198506091957 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-22 00198506092848 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-22 00198506092862 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-22 14026704645333 WECK TELEFLEX INCORPORATED GCJ 2026-07-21 00198506092176 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-17 00888867561793 Arthrex® ARTHREX, INC. GCJ 2026-07-17 B382SD90781001000 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-17 B382SD9918100 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-17 B382SD1184590 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD12711090 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD1271390 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD1271590 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD13018770 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD13168350 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD23373490 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD770561050 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD775011530 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD775021630 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD77505650 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD7751586C0 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD7751587C0 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 00850045863012 ArthroFree® 2 Receiver Lazurite Holdings LLC GCJ 2026-07-10 00850045863029 ArthroFree® 2 Wireless Camera Head Lazurite Holdings LLC GCJ 2026-07-10 00850045863036 ArthroFree® 2 Operating Room Kit Lazurite Holdings LLC GCJ 2026-07-10 00850045863043 ArthroFree® 2 Single Camera Head Set Lazurite Holdings LLC GCJ 2026-07-10 B382SD883110450 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-10 B382SD88324450 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-10 00817401029178 Endoplus Endoplus HET 2026-07-08 00190776421731 Millennium Avalign Technologies, Inc. GCJ 2026-06-24