DBC Sooji Hand Needle

Basic Information

• Brand Name: DBC Sooji Hand Needle
• Primary DI: 18800018900434
• Version / Model: SooJi.Hand
• Catalog Number: SooJi.Hand
• Company Name: Dong Bang Medical co.,Ltd.
• Labeler DUNS: 689846367
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• 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: b7a5f72b-7fd3-4d04-8b36-7f0067095193

Device Description

SooJi DBC Hand Needles are sterile disposable, stainless steel hand needles with "spring" style metal handle. Box contains 10 needles arranged for easy access in foam. 2 (0.18) x 8mm needle, with 13mm handle. Box of 100 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	38800018900438	GS1	Master Case	10	In Commercial Distribution
Package	28800018900431	GS1	Case	10	In Commercial Distribution
Primary	18800018900434	GS1
Unit of Use	08800018900437	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			0.18 mm x 8 mm