DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)

Basic Information

• Brand Name: DB_108, Spring bulk 10 + 1 Tube (Pouch Pack)
• Primary DI: 18800018909055
• Version / Model: 4GS25-4025
• Company Name: Dong Bang Medical co.,Ltd.
• Labeler DUNS: 689846367
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2024-10-25
• Public Version: 1
• Public Version Date: 2024-11-04
• Public Version Status: New
• Public Device Record Key: 844c55f9-3a50-4e2b-a9b7-0c212875f69b

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
Package	28800018909052	GS1	outbox	10000	In Commercial Distribution
Primary	18800018909055	GS1
Package	38800018909059	GS1	carton box	100000	In Commercial Distribution
Unit of Use	08800018909058	GS1

Premarket Submissions

Submission Number	Supplement Number
K990328	000