ARMI

GUDID 16973672291186

ARMI® Single-Use Hysteroscope

Jiangsu Jiyuan Medical Technology Co .,Ltd.

Rigid video hysteroscope

• Primary Device ID: 16973672291186
• NIH Device Record Key: aca136a0-25c4-4555-8698-3dba543d0d22
• Commercial Distribution Discontinuation: 2056-08-18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARMI
• Version Model Number: SH-03C
• 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: 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	06973672291189 [Primary]
GS1	16973672291186 [Package]; Contains: 06973672291189; Package: carton [20 Units]; Discontinued: 2056-08-18; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252793

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: 2026-02-02
• Device Publish Date: 2026-01-23

On-Brand Devices [ARMI]

• 06973672291196: ARMI® Endoscopic Video Image Processor
• 16973672291186: ARMI® Single-Use Hysteroscope
• 16973672291179: ARMI® Single-Use Hysteroscope
• 16973672291162: ARMI® Single-Use Hysteroscope
• 16973672291155: ARMI® Single-Use Hysteroscope