Combo-Pak

Basic Information

• Brand Name: Combo-Pak
• Primary DI: 60888937011144
• Version / Model: 908010CP
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: ec389bfa-3dc2-414b-91c2-cd644ef0c3a8

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	884.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11531	Endometrial biopsy kit	A collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	60888937011144	GS1

Premarket Submissions

Submission Number	Supplement Number
K001545	000