Epimed

Basic Information

• Brand Name: Epimed
• Primary DI: 00818788020482
• Version / Model: 116-2535
• Catalog Number: 116-2535
• Company Name: EPIMED INTERNATIONAL, INC
• Labeler DUNS: 799751953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-20
• Public Version: 4
• Public Version Date: 2023-08-09
• Public Version Status: Update
• Public Device Record Key: bed2a990-dc93-45bb-bc2a-889fdcd596d6

Device Description

25g RW x 3.5" Blunt Nerve Block Needle w/ Introducer

Device Characteristics

• Single Use: Yes
• 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: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• 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
BSP	NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)	Anesthesiology	868.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59012	Peripheral nerve-block blunt needle access cannula	A sterile flexible tube designed to provide percutaneous access to a peripheral nerve group for the insertion of a nerve-block blunt needle and injection of an anaesthetic/analgesic agent for nerve-block/pain control. It is typically made of plastic and contains a sharp-tipped metal needle to facilitate its introduction which may be guided by fluoroscopy. Once introduced, the sharp needle is intended to be removed so the cannula can be used as a conduit for the nerve-block blunt needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818788020489	GS1	Case	10	In Commercial Distribution
Primary	00818788020482	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K041843	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	25	Gauge
Device Size Text, specify			3.5"
Length	3.5	Inch
Device Size Text, specify			25g RW

Storage Conditions

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