Epimed

Basic Information

• Brand Name: Epimed
• Primary DI: 00818788021526
• Version / Model: 191-950
• Catalog Number: 191-950
• Company Name: EPIMED INTERNATIONAL, INC
• Labeler DUNS: 799751953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-24
• Public Version: 9
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: 9b1d28c2-e318-4043-9d95-e1f563160e13

Device Description

Double Deck Prep Tray

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRO	General surgery tray	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65161	Instrument tray, single-use	A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure. It is in the form of a shallow receptacle with a raised rim and moulded positions for placing the instruments. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818788021523	GS1	Case	10	In Commercial Distribution
Primary	00818788021526	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit