H/S Elliptosphere™ Procedure Tray • 5 French

GUDID 20888937016462

H/S Elliptosphere™ Procedure Tray • 5 French for Hysterosonography and Hysterosalpingography

Coopersurgical, Inc.

Fallopian tube catheterization kit

• Primary Device ID: 20888937016462
• NIH Device Record Key: 810be1f4-9619-4ef4-8180-0c40e5695c47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H/S Elliptosphere™ Procedure Tray • 5 French
• Version Model Number: 61-4205
• 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: true
• 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	20888937016462 [Package]; Contains: 60888937016460; Package: [10 Units]; In Commercial Distribution
GS1	60888937016460 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-04

Devices Manufactured by Coopersurgical, Inc.

• 00888937028331 - ORIGIO Sequential Blast: 2026-02-13 ORIGIO Sequential Blast. 10 ml
• 00888937028348 - ORIGIO Sequential Blast: 2026-02-13 ORIGIO Sequential Blast 60 ml
• 00888937028355 - ORIGIO Sequential Blast: 2026-02-13 ORIGIO Sequential Blast with phenol red. 10 ml
• 00888937028386 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav. 10 ml
• 00888937028393 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav. 60 ml
• 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
• 00888937028430 - ORIGIO Sequential Fert: 2026-02-13 ORIGIO Sequential Fert