Disposable Dilators

Basic Information

• Brand Name: Disposable Dilators
• Primary DI: 00878953005379
• Version / Model: 720131-01
• Company Name: AMERICAN MEDICAL SYSTEMS, INC.
• Labeler DUNS: 125111448
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-25
• Public Version: 4
• Public Version Date: 2019-02-13
• Public Version Status: Update
• Public Device Record Key: ae0a73b7-3b70-4e16-8ecb-c228ff09830f

Device Description

Disposable Dilators, Set of 2 Dilators (9-12 mm) 1) 9-10 mm Dilator 1) 11-12 mm Dilator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58389	Corpus cavernosum dilator, single-use	A sterile, hand-held, manual surgical instrument designed to dilate the corpora cavernosa of the penis prior to the insertion of a penile prosthesis. The device is rod-like in design and typically made of plastic; it is available in a set of graduated sizes that are applied in succession. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00878953005379	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			9 to 10 mm
Device Size Text, specify			11 to 12 mm