Combo-Pak

GUDID 60888937011144

Convenience Kit; Contents: 25 Endometrial Cell Samplers and 6 Os Finders

Coopersurgical, Inc.

Endometrial biopsy kit

• Primary Device ID: 60888937011144
• NIH Device Record Key: ec389bfa-3dc2-414b-91c2-cd644ef0c3a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Combo-Pak
• Version Model Number: 908010CP
• 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	60888937011144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001545

FDA Product Code

• HHK: Curette, Suction, Endometrial (And Accessories)

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: 2016-09-21

On-Brand Devices [Combo-Pak]

• 60888937011144: Convenience Kit; Contents: 25 Endometrial Cell Samplers and 6 Os Finders
• 60888937011120: Convenience kit; Contents: 25 Pipelle Endometrial Suction Curettes and 6 Os Finders