HBW UNISHARP

Basic Information

• Brand Name: HBW UNISHARP
• Primary DI: 00816073022937
• Version / Model: L Type No.36G x 15mm
• Catalog Number: L3605
• 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: 2019-09-09
• Public Version: 1
• Public Version Date: 2019-09-17
• Public Version Status: New
• Public Device Record Key: 56d763c2-0bbd-4988-b311-2c34bb2bd2d1

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. One needle with one insertion tube per sterile, individually sealed blister package. Needles are secured in guide tubes without tab for easy gauge identification. Box of 100 needles, 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
Primary	00816073022937	GS1
Unit of Use	10816073022934	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.18 x 15mm