TEWA

Basic Information

• Brand Name: TEWA
• Primary DI: 04251282504151
• Version / Model: CJ-Type 35100(s) Safe-T Sleeve
• Catalog Number: A000502
• Company Name: asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG
• Labeler DUNS: 327997797
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-08-30
• Public Version: 6
• Public Version Date: 2023-03-27
• Public Version Status: Update
• Public Device Record Key: 827cae8c-1f47-4934-bfd4-417dad80cd11
• Distribution End Date: 2018-07-31

Device Description

TeWa CJ-Type 35100(s) Safe-T Sleeve: uncoated acupuncture needles with copper-wire handle|with Safe-T Sleeve guide tube|Packaging: 1 needle per blister|Size: Gauge 10(x 4.0") / 0.35 x 100 mm|Color code: black|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
Package	4251282504168	GS1	parcel	10	Not in Commercial Distribution	2018-07-31
Primary	04251282504151	GS1
Unit of Use	04251282504144	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.35	Millimeter
Length	100	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 8 – 35 Degrees Celsius