Intimate Rose

Basic Information

• Brand Name: Intimate Rose
• Primary DI: 00850005838494
• Version / Model: IR-035-2
• Company Name: PLUS EV HOLDINGS INC.
• Labeler DUNS: 054962595
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-10
• Public Version: 1
• Public Version Date: 2024-12-18
• Public Version Status: New
• Public Device Record Key: 49bbf391-e1c4-4cb1-b3f4-857b75155e30

Device Description

Intimate Rose Rectal Dilator Size 2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• 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: 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
FFP	Dilator, Rectal	Gastroenterology, Urology	876.5450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11262	Rectal dilator, reusable	A surgical instrument designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850005838494	GS1

Customer Contacts

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