TEWA

Basic Information

• Brand Name: TEWA
• Primary DI: 04251282515409
• Version / Model: KJ-Type 3050
• Catalog Number: A012552
• Company Name: asia-med GmbH
• Labeler DUNS: 333450844
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-03-23
• Public Version: 1
• Public Version Date: 2023-03-31
• Public Version Status: New
• Public Device Record Key: 215dc70a-10bf-4576-b314-0d4c313ef4f3

Device Description

TeWa KJ-Type 3050: coated acupuncture needles with Korean style, non-looped steel coil handle|with guide tube|Packaging: 1 needle per blister|Size: Gauge 8(x 2.0") / 0.30 x 50 mm|Color code: yellow|Sales unit: 100 pieces

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: 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	04251282515393	GS1
Primary	04251282515409	GS1
Package	04251282515416	GS1	parcel	10	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	50	Millimeter
Outer Diameter	0.30	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 8 – 25 Degrees Celsius