NA

Basic Information

• Brand Name: NA
• Primary DI: 04715309124772
• Version / Model: CuRs08
• Company Name: PANPAC MEDICAL CORPORATION
• Labeler DUNS: 657528899
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-10
• Public Version: 4
• Public Version Date: 2020-06-25
• Public Version Status: Update
• Public Device Record Key: e93cfa15-5d51-4c62-8556-7f3505dfff06

Device Description

"Measure uterine depth. Dilate the cervix if necessary. Introduce INTRACURETTE through the cervical canal into the uterus up to the fundus. Connect the curette to the suction system. Operate by rotating the curette 360∘ to aspirate throughout the uterus cavity accurately. Repeat the operation two or three times. Withdraw INTRACURETTE from the uterus while continuing the rotating movement. "

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• 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
HGH	Cannula, Suction, Uterine	Obstetrics/Gynecology	884.5070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47341	Intrauterine curette, suction	A sterile, tubular, semi-rigid, hand-held device used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device typically has a rounded blunt nose and an opening(s) with a blunt scraping edge(s) at the distal end. It is connected at the proximal end to tubing and a suction source, typically an abortion suction system, which provides regulated suction. Also known as a pregnancy termination catheter, it is typically made of plastic and is available in various shapes and sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04715309125298	GS1	BOX	10	In Commercial Distribution
Primary	04715309124772	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K161106	000