AcuRight

Basic Information

• Brand Name: AcuRight
• Primary DI: 04719674800613
• Version / Model: C-type 0.30*50mm
• Company Name: SUN TEN PHARMACEUTICAL CO., LTD.
• Labeler DUNS: 656338282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2020-09-11
• Public Version: 1
• Public Version Date: 2020-09-21
• Public Version Status: New
• Public Device Record Key: b96cd577-7ab4-45c5-9f94-5138c5145ea5

Device Description

AcuRight Traditional Stainless Steel Wired Handle with Loop Acupuncture Needles with size 0.30*50mm. 500 Needles and 50 Guide tubes per box.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
Unit of Use	14719674800610	GS1
Primary	04719674800613	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.30*50mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid high temperature and humidity