AccessGUDID - DEVICE: Jiyuan (06973672290243)

GUDID

Device Identifier (DI) Information

Brand Name: Jiyuan
Version or Model: JY-JD-17-350-B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Jiangsu Jiyuan Medical Technology Co .,Ltd.

Primary DI Number: 06973672290243
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 2056
Device Count: 1
Labeler D-U-N-S® Number*: 414764719 *Terms of Use

Device Description: working length 350mm, diameter 1.7mm

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
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?
63163	Rigid endoscopic scissors, single-use	A sterile, rigid surgical instrument designed to be introduced through an endoscope (e.g., laparoscope, hysteroscope) or laparoscopic port, to mechanically cut tissues during an endoscopic/laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles, a long slender shaft, and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., straight scissor, bend scissor) controlled by a knob at the handle; it is not an electrosurgical device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWW	Hysteroscope Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e8bfb73a-4073-4f41-9673-80ef394504c9
Public Version Date: June 23, 2023
Public Version Number: 1
DI Record Publish Date: June 15, 2023