AccessGUDID - DEVICE: 4K UHD Laparoscope (06971381250251)

GUDID

Device Identifier (DI) Information

Brand Name: 4K UHD Laparoscope
Version or Model: 4K1000R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SCIVITA MEDICAL TECHNOLOGY CO., LTD.

Primary DI Number: 06971381250251
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544519831 *Terms of Use

Device Description: The product is composed of eyepiece, lens body, optic fiber interface.The 4K UHD Laparoscope is 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
12291	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	Laparoscope, Gynecologic (And Accessories)
NMH	Laparoscope And Accessories, Gynecologic, Reprocessed
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203255	000
K221252	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Hydrogen Peroxide
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 29711c47-9051-4c3d-99b5-590417cac463
Public Version Date: April 14, 2025
Public Version Number: 5
DI Record Publish Date: May 17, 2023