LEEP Endocervical Speculum

Basic Information

• Brand Name: LEEP Endocervical Speculum
• Primary DI: 00888937016246
• Version / Model: F500
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-16
• Public Version: 3
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: dfa74c97-d571-4389-9f87-e599784327fc

Device Description

LEEP Endocervical Speculum - Coated- Large

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16469	Manual expandable cervical dilator	A forceps-like surgical instrument designed to manually dilate the cervical canal after its insertion through the cervical os. It is typically constructed with two pivoted handles and opposing blunted blades that expand outward when the handles are manually squeezed, and possibly locked, dilating the cervical canal. This process is used to allow the passage of a curette or other instruments into the uterus. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888937016246	GS1