KP

Basic Information

• Brand Name: KP
• Primary DI: 06975384330019
• Version / Model: iSee 9000
• Company Name: Guilin Kevin Peter Technology Co., Ltd.
• Labeler DUNS: 621948840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-24
• Public Version: 1
• Public Version Date: 2023-11-01
• Public Version Status: New
• Public Device Record Key: 8bc5db35-6699-4d94-96f5-a5d5a960a24a

Device Description

iSee 9000 surgical microscope is mainly used for microsurgery and meticulous examination.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EPT	Microscope, Surgical	General, Plastic Surgery	878.4700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62439	Dental surgical microscope	A light (optical) magnification instrument intended to be used to magnify and visualize minute intraoral structures during dental examination and dental surgical procedures via transmission of white and/or ultraviolet light. It typically consists of a control unit, eyepiece and magnification controls, and a white and fluorescent light module to enable differentiation of natural tooth material suggesting dental pathology (e.g., caries, plaque, calculus/tartar) or composite material used for dental repairs. It may also include a camera for still image capture or video recording.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06975384330019	GS1