WiScope

GUDID 06973672290410

Single-Use Digital Hysteroscope

Jiangsu Jiyuan Medical Technology Co .,Ltd.

Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope Rigid video hysteroscope

• Primary Device ID: 06973672290410
• NIH Device Record Key: 06d2bb6b-3049-4715-8007-c3753c7c00d2
• Commercial Distribution Discontinuation: 2056-08-18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WiScope
• Version Model Number: OTU-HJ01
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973672290410 [Primary]
GS1	16973672290417 [Package]; Package: carton [20 Units]; Discontinued: 2056-08-18; In Commercial Distribution

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: 2024-03-19
• Device Publish Date: 2024-03-11

Devices Manufactured by Jiangsu Jiyuan Medical Technology Co .,Ltd.

• 16973672290424 - Jiyuan: 2024-04-22 Coarse-tooth type, 350mm, diameter 1.5mm,
• 16973672290431 - Jiyuan: 2024-04-22 working length 450mm, diameter 1.7mm
• 06973672290410 - WiScope: 2024-03-19Single-Use Digital Hysteroscope
• 06973672290410 - WiScope: 2024-03-19 Single-Use Digital Hysteroscope
• 06973672290274 - Jiyuan: 2023-08-17 C type, 350mm, diameter 1.8mm
• 16973672290295 - Jiyuan: 2023-08-17 Inverted type, 350mm, diameter 1.8mm
• 06973672290243 - Jiyuan: 2023-06-23 working length 350mm, diameter 1.7mm
• 06973672290045 - Jiyuan: 2022-11-17 Coarse-tooth type, 350mm, diameter 1.8mm,10pcs/box,the minimum sales packaging is paper box.
• 16973672290042 - Jiyuan: 2022-06-21 Coarse-tooth type, 350mm, diameter 1.8mm, ARMI