Jiyuan

GUDID 16973672290028

Disposable electronic hysteroscope, Blue

Jiangsu Jiyuan Medical Technology Co .,Ltd.

Rigid video hysteroscope

• Primary Device ID: 16973672290028
• NIH Device Record Key: 39d93932-dda7-4df8-b653-362d1edf78da
• Commercial Distribution Discontinuation: 2056-08-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jiyuan
• Version Model Number: JY-DEH-003
• Company DUNS: 414764719
• Company Name: Jiangsu Jiyuan Medical Technology Co .,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	16973672290028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210270

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-17
• Device Publish Date: 2022-02-09

On-Brand Devices [Jiyuan]

• 16973672290028: Disposable electronic hysteroscope, Blue
• 16973672290011: Disposable electronic hysteroscope, Grey, Corrugated carton, 20 boxes/carton
• 16973672290004: Disposable electronic hysteroscope, Black, CARTON, 20boxes/carton
• 06973672290038: CVBS/HDMI
• 06973672290021: Disposable electronic hysteroscope, blue,
• 06973672290014: Disposable electronic hysteroscope, Grey CARTON, 20boxes/carton
• 06973672290007: black
• 16973672290059: Flat type, 350mm, diameter 1.8mm, ARMI
• 16973672290042: Coarse-tooth type, 350mm, diameter 1.8mm, ARMI
• 06973672290045: Coarse-tooth type, 350mm, diameter 1.8mm,10pcs/box,the minimum sales packaging is paper box.
• 06973672290243: working length 350mm, diameter 1.7mm
• 16973672290295: Inverted type, 350mm, diameter 1.8mm
• 06973672290274: C type, 350mm, diameter 1.8mm
• 16973672290431: working length 450mm, diameter 1.7mm
• 16973672290424: Coarse-tooth type, 350mm, diameter 1.5mm,