NA

Basic Information

• Brand Name: NA
• Primary DI: 08057509880031
• Version / Model: CO7026
• Company Name: INGE SPA
• Labeler DUNS: 338946150
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 21
• Record Status: Published
• Publish Date: 2022-07-17
• Public Version: 2
• Public Version Date: 2022-08-25
• Public Version Status: Update
• Public Device Record Key: d91db36b-98b6-425a-9123-4a064100aeaa

Device Description

Kit including 21 cannulas for administering semi-solid preparation into the vagina

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGD	Applicator, Vaginal	Obstetrics/Gynecology	884.4520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32652	Vaginal applicator, reusable	A device designed to apply medication to the vagina. It is typically a hand-held bulb, pump, or injector used to introduce medicated powder or other substances into the vagina either directly or through an open speculum. It is typically used to treat vaginitis but can be used for other forms of vaginal treatment. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08057509880031	GS1
Unit of Use	08057509880024	GS1