ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00842180163737
• Version / Model: 31-1450-005
• Catalog Number: 31-1450-005
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-21
• Public Version: 1
• Public Version Date: 2023-05-01
• Public Version Status: New
• Public Device Record Key: 26672090-898f-4374-ad75-9671e26f5585

Device Description

PRATT Uterine Dilators. Solid, double-ended. Mirror finish. Overall length 11-3/8in (28.9cm). Size 29-31Fr

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: Yes
• 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	00842180163737	GS1

Customer Contacts

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