MED pro Medical B.V.

Basic Information

• Brand Name: MED pro Medical B.V.
• Primary DI: 08718455508270
• Version / Model: MD6/16
• Company Name: MED pro Medical B.V.
• Labeler DUNS: 490059139
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-09
• Public Version: 1
• Public Version Date: 2022-09-19
• Public Version Status: New
• Public Device Record Key: 1f173819-bbd8-4370-a902-ed3105ea2fe3

Device Description

Meatal Dilator 6/16

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KOE	Dilator, Urethral	Gastroenterology, Urology	876.5520	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64677	Urethral dilator, single-use	A slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08718455508270	GS1

Device Sizes

Type	Value	Unit	Text
Length	9	Centimeter
Device Size Text, specify			6-16 French