ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00842180178144
• Version / Model: E32-1540
• Catalog Number: E32-1540
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-05
• Public Version: 1
• Public Version Date: 2023-10-13
• Public Version Status: New
• Public Device Record Key: c549896c-4a8d-4736-955d-453dbec8547f

Device Description

HEMOSTATIC CLIP APPLIERS-MEDIUM LARGE GREEN, CURVED, 8" (20.3CM) LENGTH,, FOR USE WITH MEDIUM-LARGE TITANIUM CLIPS. REUSABLE/ AUTOCLAVABLE 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: 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
GDO	Applier, Surgical, Clip	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35649	Ligation clip, metallic	A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842180178144	GS1

Customer Contacts

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