ELMED

Basic Information

• Brand Name: ELMED
• Primary DI: 00842180163508
• Version / Model: 24-8100
• Catalog Number: 24-8100
• Company Name: ELMED INCORPORATED
• Labeler DUNS: 049290364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-06
• Public Version: 1
• Public Version Date: 2023-04-14
• Public Version Status: New
• Public Device Record Key: 29ac1016-61f6-44aa-b849-d87fc0f7b11b

Device Description

"Cooley Cosgrove Mitral Valve Heart Retractor Complete Set Includes the below: (1) Cooley Rib Spreader Adult Blades 40* 110mm With Cosgrove mounting Bars (1) Main Bracket Attachment (3) Universal Clamps (1) Side Arm Bar (1) Tricuspid Retractor Blade (1) Large Retractor Blade (3) Small Retractor Blades"

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
GAD	Retractor	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45181	Surgical retraction system, reusable	A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842180163508	GS1

Customer Contacts

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