ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00842180165281
• Version / Model: 16-165
• Catalog Number: 16-165
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-20
• Public Version: 1
• Public Version Date: 2023-03-28
• Public Version Status: New
• Public Device Record Key: 8ef45365-1ac8-4374-91e0-f37520534c43

Device Description

Yankauer suction tubes, Half-curved, with additional slight curved near the tip. Large, light, hollow handle. Overall length 10-3/4in (27.3cm). Mirror finish

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
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64101	Thyroglobulin neutralizing antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of neutralizing antibodies to thyroglobulin in a clinical specimen, using thyroglobulin antigens of known specificity.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842180165281	GS1

Customer Contacts

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