ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00842180170261
• Version / Model: 71410-20
• Catalog Number: 71410-20
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-10
• Public Version: 1
• Public Version Date: 2023-07-18
• Public Version Status: New
• Public Device Record Key: b262266c-72b2-4297-9065-f6013b5d27ef

Device Description

Single Ended Hegar Dilator, 20mm Tip, Autoclavable Medical Grade Stainless Steel

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HDX	Dilator, Vaginal	Obstetrics/Gynecology	884.3900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11261	Pulmonary dilator	A surgical instrument used during a surgical procedure to enlarge or open/clear a pulmonary structure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842180170261	GS1

Customer Contacts

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