Applanation Tonometer

GUDID 26973211070491

It is a manual device intended for measurement of intraocular pressure by applanation (applying a small flat disk to the cornea) to aid the diagnosis of glaucoma

CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD

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• Primary Device ID: 26973211070491
• NIH Device Record Key: 5d25bd96-426b-4022-954b-ea27716bea9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Applanation Tonometer
• Version Model Number: SK-R
• Company DUNS: 545824560
• Company Name: CHONGQING SUNKINGDOM MEDICAL INSTRUMENT 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: false
• 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	06973211070671 [Primary]
GS1	26973211070491 [Package]; Contains: 06973211070671; Package: [2 Units]; In Commercial Distribution
GS1	26973211070507 [Package]; Contains: 06973211070671; Package: [4 Units]; In Commercial Distribution
GS1	26973211070514 [Package]; Contains: 06973211070671; Package: [6 Units]; In Commercial Distribution
GS1	26973211070521 [Package]; Contains: 06973211070671; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191314

FDA Product Code

• HKY: Tonometer, Manual

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: 2020-07-10
• Device Publish Date: 2020-07-02

On-Brand Devices [Applanation Tonometer]

• 26973211070491: It is a manual device intended for measurement of intraocular pressure by applanation (applying
• 26973211070453: It is a manual device intended for measurement of intraocular pressure by applanation (applying
• 26973211070415: It is a manual device intended for measurement of intraocular pressure by applanation (applying