HNM Women Care

Basic Information

• Brand Name: HNM Women Care
• Primary DI: 00812171027539
• Version / Model: HUA-1151
• Catalog Number: HUA-1151
• Company Name: HNM STAINLESS, LLC.
• Labeler DUNS: 806754185
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2019-05-16
• Public Version: 2
• Public Version Date: 2023-03-06
• Public Version Status: Update
• Public Device Record Key: 5c6f9b9d-721a-4b98-b602-8f7e99d9b406

Device Description

UTERINE MANIPULATOR/INJECTOR, 4.5mm, STERILE, BOX OF 12

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: 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: 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
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42912	Hysterosonography/endometrial biopsy catheter	A flexible tube designed for combined saline infusion sonohysterography (SIS) and biopsy functionality providing the physician with increased visibility offered by a sonohysterography during a diagnostic image ultrasound and the ability to take a biopsy of endometrial tissue during the same gynaecological procedure. It is introduced via the vagina and allows the uterus to be filled with saline which is retained with an acorn-tipped stopper placed against the cervical opening; a biopsy can be taken if indicated. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812171027539	GS1
Unit of Use	00842962101322	GS1