Milex Vaginal Dilator Set

Basic Information

• Brand Name: Milex Vaginal Dilator Set
• Primary DI: 60888937016743
• Version / Model: MX20
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-22
• Public Version: 3
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: 02384d69-86e3-48aa-bdaf-d872c3cc2734

Device Description

Vaginal Dilator Set- Hymenal - (1) Small (1) Medium (1) Large (1) X-Large

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFP	Dilator, Rectal	Gastroenterology, Urology	876.5450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11267	Vaginal dilator	A firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	60888937016743	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Length x outer diameter = 130 mm x 24 mm
Device Size Text, specify			length x outer diameter = 140 mm x 28 mm
Device Size Text, specify			length x outer diameter = 146 mm x 32 mm
Device Size Text, specify			length x outer diameter = 157 mm x 38 mm