HBW HI.CHI

Basic Information

• Brand Name: HBW HI.CHI
• Primary DI: 00816073021749
• Version / Model: HP Type No.36G x 15mm
• Catalog Number: HP3605
• Company Name: HEALTH BODY WORLD SUPPLY, INC.
• Labeler DUNS: 061228290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7f5e2285-3f90-42af-8dcc-23c29d578485

Device Description

The ergonomically optimized and precisely centered handle ensures safe and convenient use. Measuring 2.0 x 20 mm, the handle is made of extremely lightweight and environmentally-friendly polypropylene plastic with Color-coded handles for easy gauge identification. Light Touch Insertion, the needle is easily released from its guide tube by gently pressing the needle away from its point of attachment on the tube, easy peel-open blister packaging. The needle is made of the highest quality surgical stainless steel. At the tip, it is filed to diamond sharpness and polished, making insertion particularly easy for the therapist and practically painless for the patient. Box of 100. Size: 36G x 15mm.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• 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
MQX	Needle, Acupuncture, Single Use	General Hospital	880.5580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34175	Acupuncture needle, single-use	A sterile, long, slender, sharply-pointed instrument used to stimulate peripheral nerves in order to produce surgical anaesthesia, relieve pain, and to promote other therapeutic effects. It is widely used in complementary therapy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20816073021743	GS1	Case	10	In Commercial Distribution
Primary	00816073021749	GS1
Unit of Use	10816073021746	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.20 x 15mm