HBW UNISHARP

Basic Information

• Brand Name: HBW UNISHARP
• Primary DI: 00816073022906
• Version / Model: T Type No.30G x 40m
• Catalog Number: T3015
• Company Name: HEALTH BODY WORLD SUPPLY, INC.
• Labeler DUNS: 061228290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2019-09-09
• Public Version: 1
• Public Version Date: 2019-09-17
• Public Version Status: New
• Public Device Record Key: 86236d42-a66a-475e-9b05-87954da1692b

Device Description

Painless HBW UNISHARP needles are made of surgical stainless steel with 25mm long spring style metal handle without loop, Lightweight, affordable price with a high quality. 10 needles with one insertion tube per sterile, individually packed a pouch. Needles are secured in guide tubes without tab for easy gauge identification. Box of 1000 needles, Size 30G x 40mm.

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
Primary	00816073022906	GS1
Unit of Use	10816073022903	GS1

Customer Contacts

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