NA

Basic Information

• Brand Name: NA
• Primary DI: 04715309125038
• Version / Model: WC-400MM
• 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: f5896f4b-2fbf-4b61-84c9-f9011a24276e

Device Description

The Word/Bartholin Catheter is used for the treatment of abscesses and cysts of the Bartholin gland.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42325	Cervical anaesthesia kit	A collection of sterile devices designed to deliver an analgesic or anaesthetic agent to function as an intracervical nerve-block and/or a paracervical regional nerve-block (sometimes including uterosacral and pudendal regions). It is typically used for gyneacological diagnostic tests such as dilation and curettage, small excisional procedures such as endometrial biopsy, or for pain management during labour and/or delivery. It typically consists of a procedural needle, syringe, catheter, and a filter. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04715309121986	GS1	BAG	1	In Commercial Distribution
Primary	04715309125038	GS1

Customer Contacts

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