Expert

Basic Information

• Brand Name: Expert
• Primary DI: 00807689100416
• Version / Model: EP10-1815
• Catalog Number: NA-EP10-1815
• Company Name: C A I INDUSTRIES CORP
• Labeler DUNS: 859060303
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2017-04-03
• Public Version: 5
• Public Version Date: 2024-01-01
• Public Version Status: Update
• Public Device Record Key: c7bd0a0c-cf68-4d32-9278-2702fbe5bc45

Device Description

0.18x15mm acupuncture needles (10 needles with one tube per pack, 1000 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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	00807689100416	GS1
Unit of Use	00807689101413	GS1

Premarket Submissions

Submission Number	Supplement Number
K970574	000

Device Sizes

Type	Value	Unit	Text
Length	0.5	Inch
Needle Gauge	38	Gauge