NA

Basic Information

• Brand Name: NA
• Primary DI: 04715309125243
• Version / Model: BA8200
• Company Name: PANPAC MEDICAL CORPORATION
• Labeler DUNS: 657528899
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 5
• Public Version Date: 2022-11-07
• Public Version Status: Update
• Public Device Record Key: 7dd36175-69f8-4b9b-ae87-411d6e8f545a

Device Description

"The ETO Sterilized Preferred Curette is used to obtain a sample from the uterine mucosal lining. The Preferred Curette is a 3mm (O.D.), or 3.6 mm (O.D.) suction curette and is sterile unless the package is opened or damaged. The Preferred Curette is designed for single patient use only. "

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
Package	04715309122938	GS1	BOX	25	In Commercial Distribution
Primary	04715309125243	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]