Epimed

Basic Information

• Brand Name: Epimed
• Primary DI: 00818788022738
• Version / Model: 410-146H
• Catalog Number: 410-146H
• 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: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d79489b0-0f8d-4b5d-9c1c-d79fde447bfb

Device Description

PainBlocker™ 14g x 6" Hemi Cryoneuroablation Probe

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: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXH	DEVICE, SURGICAL, CRYOGENIC	Neurology	882.4250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17140	Cryogenic analgesia unit	A device designed to provide analgesia (the alleviation of pain) by applying extremely low temperatures (freezing) to body tissues. The device consists of a cryostat and cooling probe, and sometimes a peripheral nerve-block stimulator (nerve stimulator). This device will incorporate some method of protecting the tissue it is being applied to against permanent damage (e.g., freeze-thaw cycles). Cryogenic analgesia results in reversible, though prolonged (weeks/months), peripheral nerve-block and is used for postoperative and chronic intractable pain relief.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818788022738	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			14g
Outer Diameter	0.072	Inch
Length	6	Inch
Device Size Text, specify			6.0"

Storage Conditions

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