GyneCath H/S Procedure Tray

GUDID 20888937016578

GyneCath H/S Procedure Tray- 5F- for Hysterosonography and Hysterosalpingography

Coopersurgical, Inc.

Fallopian tube catheterization kit

• Primary Device ID: 20888937016578
• NIH Device Record Key: 934f2403-6f9c-4b65-8add-449c55c828eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GyneCath H/S Procedure Tray
• Version Model Number: 19612
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20888937016578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020954

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

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: 2022-12-07
• Device Publish Date: 2022-11-29

Devices Manufactured by Coopersurgical, Inc.

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• 00888937028355 - ORIGIO Sequential Blast: 2026-02-13 ORIGIO Sequential Blast with phenol red. 10 ml
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• 00888937028409 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav with phenol red. 10 ml
• 00888937028416 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav with phenol red. 60 ml