IwavePhoropter

GUDID 06971053610017

Krypton Vision (Suzhou) Ltd.

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• Primary Device ID: 06971053610017
• NIH Device Record Key: 78ffb60d-ff50-410a-b014-bbbb31983819
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IwavePhoropter
• Version Model Number: IwavePhoropter
• Company DUNS: 543911771
• Company Name: Krypton Vision (Suzhou) Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971053610017 [Primary]

FDA Product Code

• HKN: Refractor, Manual, Non-Powered, Including Phoropter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-23