MediWorks

GUDID 06945087528013

AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu

SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.

Ophthalmic slit lamp, examination

• Primary Device ID: 06945087528013
• NIH Device Record Key: f9e16cc0-23ca-4d75-afbf-63927ba6e19b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MediWorks
• Version Model Number: S280
• Company DUNS: 527884077
• Company Name: SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945087528013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100439

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-01

On-Brand Devices [MediWorks]

• 06945087562017: Operation microscope used for observation of surgical and other medical procedures,consisting of
• 06945087539026: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segm
• 06945087539019: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segm
• 06945087536025: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segm
• 06945087536018: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segm
• 06945087535035: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segm
• 06945087535028: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segm
• 06945087535011: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segm
• 06945087528037: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segm
• 06945087528020: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segm
• 06945087528013: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segm
• 06945087526026: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segm
• 06945087526019: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segm
• 06945087517024: Tonometer is indicated for Intraocular Pressure (IOP) measurement .
• 06945087517017: Tonometer is indicated for Intraocular Pressure (IOP) measurement .
• 06945087516010: The device is used to observe, capture and record retina images through examining pupil.
• 06945087510018: The vision screening instrument is based on the principle of eccentric photo refraction and i
• 06945087561010: Operation microscope used for observation of surgical and other medical procedures,consisting of
• 06945087505175: Scansys TA517
• 06945087516102: FC161
• 06945087590119: C901
• 06945087530016: Slit Lamp Microscopes are used to observe the disease of the anterior structures and tissue dama
• 06945087545027: Slit Lamp Microscopes are used to observe the disease of the anterior structures and tissue dama
• 06945087545010: Slit Lamp Microscopes are used to observe the disease of the anterior structures and tissue dama
• 06945087540022: Slit Lamp Microscopes are used to observe the disease of the anterior structures and tissue dama
• 06945087540015: Slit Lamp Microscopes are used to observe the disease of the anterior structures and tissue dama
• 06945087535073: Slit Lamp Microscopes are used to observe the disease of the anterior structures and tissue dama
• 06945087535066: Slit Lamp Microscopes are used to observe the disease of the anterior structures and tissue dama
• 06945087530023: Slit Lamp Microscopes are used to observe the disease of the anterior structures and tissue dama
• 06945087590027: TSL-900Hdigital
• 06945087590010: TSL-900H
• 06945087590003: TSL-900Z
• 06945087525012: RSL 2600digital
• 06945087525005: RSL 2600
• 06945087520000: RSL 2100
• 06945087516201: FC162
• 06945087580011: TAT-80T
• 06945087580004: TAT-80R
• 06945087515013: S150
• 06945087512135: 90D
• 06945087512128: 78D
• 06945087512111: 20D
• 06945087500217: Slit Lamp Microscopes are intended to observe the disease of the anterior structures and tissue
• 06945087500088: FC163
• 06945087500071: The vision screening instrument is based on the principle of eccentric photo refraction and is u
• 06945087500057: Slit Lamp Microscopes are intended to observe the disease of the anterior structures and tissue
• 06945087500040: Slit Lamp Microscopes are used to observe the disease of the anterior structures and tissue dama
• 06945087500026: Surgical Microscope
• 06945087500002: Corneal topography system
• 06945087500064: The vision screening instrument is based on the principle of eccentric photo refraction and is u