ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00842180155701
• Version / Model: 18-2536
• Catalog Number: 18-2536
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-01
• Public Version: 1
• Public Version Date: 2023-03-09
• Public Version Status: New
• Public Device Record Key: bc473274-79bc-4187-a529-8ba1fb17b56d

Device Description

FLOSEAL NEEDLE, 15DG., BEND, FEMALE LUER LOCK, 4 1/2" OVERAL LENGTH, 3 1/2" WORKING LENGTH, 1/4" ENLARGED TIP

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
59902	X-linked spinal and bulbar muscular atrophy (Kennedy's disease) IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inherited genetic disorder x-linked spinal and bulbar muscular atrophy or Kennedy's disease, associated with mutations in the androgen receptor (AR) gene with a repeat trinucleotide (CAG) expansion, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842180155701	GS1

Customer Contacts

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