ClearVision

GUDID 06976860690382

ClearVision Single Use Hysteroscope

OriGyn Medical Technology (Hangzhou) Co., Ltd.

Rigid video hysteroscope

• Primary Device ID: 06976860690382
• NIH Device Record Key: 83d7fa5f-51c2-425c-82c2-7cfe1a5a12bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearVision
• Version Model Number: EHS-Dx4001
• Company DUNS: 413121050
• Company Name: OriGyn Medical Technology (Hangzhou) 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976860690382 [Primary]
GS1	16976860690044 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240401

FDA Product Code

• HIN: Coagulator-Cutter, Endoscopic, Bipolar (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: 2024-10-01
• Device Publish Date: 2024-09-23

On-Brand Devices [ClearVision]

• 06976860690405: ClearVision Single Use Hysteroscope
• 06976860690399: ClearVision Single Use Hysteroscope
• 06976860690382: ClearVision Single Use Hysteroscope
• 06976860690375: ClearVision Image Processing System