CARBO

Basic Information

• Brand Name: CARBO
• Primary DI: 06973169041297
• Version / Model: CZ5-3605
• Company Name: Wujiang City ShenLing Medical Device Co.,Ltd
• Labeler DUNS: 654613546
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-16
• Public Version: 2
• Public Version Date: 2025-12-29
• Public Version Status: Update
• Public Device Record Key: a14f72b4-5c70-455b-a4bf-0f5315dcc324

Device Description

Classic Series CZ5 Easy Pack

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
Primary	06973169041297	GS1

Premarket Submissions

Submission Number	Supplement Number
K002411	000