Impoaid

Basic Information

• Brand Name: Impoaid
• Primary DI: 00850358007097
• Version / Model: Ring Kit
• Catalog Number: 44023-001
• Company Name: ENCORE, INC.
• Labeler DUNS: 614647725
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2cc8f6d1-d9ff-4de2-b942-93fe67c1b40c

Device Description

Ring Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	876.5020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60659	Penile rigidity splint	A device intended to be worn externally on the penis of a patient affected by erectile dysfunction (ED) (commonly known as impotence) or premature ejaculation to support a flaccid penis during vaginal intercourse. It is typically comprised of a ring/loop worn at the base of the penis that connects, via a stabilizing rod, to another ring/loop worn at the head of the penis; it may also be intended to stimulate a penile erection. It is manufactured with specific characteristics (e.g., length, diameter) for a specified patient (i.e., custom-made) and lubricant may be included. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850358007097	GS1

Customer Contacts

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