Mediworks

GUDID 06945087590010

SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.

Ophthalmic slit lamp, examination

• Primary Device ID: 06945087590010
• NIH Device Record Key: 71507add-4638-4fa6-9cec-878ef7c227b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mediworks
• Version Model Number: TSL-900H
• 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	06945087590010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152429

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-25
• Device Publish Date: 2021-05-17

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