Juneland

Basic Information

• Brand Name: Juneland
• Primary DI: 06976143660088
• Version / Model: 008
• Company Name: Suzhou Juneland Medical Co., Ltd.
• Labeler DUNS: 414758527
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-11
• Public Version: 1
• Public Version Date: 2023-04-19
• Public Version Status: New
• Public Device Record Key: e2542bc0-b0ea-4127-9a86-de7cffb1b66d

Device Description

implant kit III

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: Yes
• 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
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45148	Dental/maxillofacial surgical procedure kit, non-medicated, single-use	A collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06976143660088	GS1