WiScope

GUDID 06973672290410

Single-Use Digital Hysteroscope

Jiangsu Jiyuan Medical Technology Co .,Ltd.

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