FDA.report

KP

Primary DI
06975384330019
Brand
KP
Company
Guilin Kevin Peter Technology Co., Ltd.
Model
iSee 9000
Device description
iSee 9000 surgical microscope is mainly used for microsurgery and meticulous examination.
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EPTMicroscope, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
EPTMicroscope, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06975384330019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06975384330019069753843300196975384330019

GMDN Terms

TermDefinition
Dental surgical microscopeA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
621948840
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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06975384334505KPKP-3504-312025-12-30
06975384334581KPKP-12vt-212025-12-30
06975384334598KPKP-12vt-252025-12-30

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