EchoStim

Basic Information

• Brand Name: EchoStim
• Primary DI: 04526737170626
• Version / Model: ES-2180
• Company Name: HAKKO CO.,LTD.
• Labeler DUNS: 693273427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2022-06-03
• Public Version Status: Update
• Public Device Record Key: fa617564-6590-46b6-a0c6-1b1835b65574

Device Description

21G x 3 1/8"(80mm) Facet tip

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
46382	Peripheral anaesthesia single-administration set, non-medicated	A collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block; it is not dedicated to dental use. It includes an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14526737170623	GS1		25	In Commercial Distribution
Primary	04526737170626	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063380	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	21	Gauge
Length	80	Millimeter