DBC Detox 5

Basic Information

• Brand Name: DBC Detox 5
• Primary DI: 18800018900847
• Version / Model: dtx.20x13
• Catalog Number: dtx.20x13
• Company Name: Dong Bang Medical co.,Ltd.
• Labeler DUNS: 689846367
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2016-08-09
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: fef58875-b4bf-4d5f-bed6-dd0562549e03

Device Description

DBC Detox 5 is new sterile, DBC needle 13mm in length with a highly visible plastic orange handle. Suitable for general and facial acupuncture, this needle is also great for those using the NADA protocol. The bright orange 25mm handle makes this needle easy to locate during removal or if dropped on the floor. Manufactured in an automated facility, this needle features consistency and quality unrivaled by other needles in the market. Box of 500 needles (100 packs of 5 needles).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
Package	38800018900841	GS1	Master Case	10	In Commercial Distribution
Package	28800018900844	GS1	Case	10	In Commercial Distribution
Primary	18800018900847	GS1
Unit of Use	08800018900840	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K990328	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.20 mm x 13 mm