Probes for HOME

GUDID 06430033850947

Sales package 20pcs of TP022 probes

ICARE FINLAND OY

Ophthalmic tonometer probe, sterile

• Primary Device ID: 06430033850947
• NIH Device Record Key: edd9e493-ffc9-4863-84bd-0fbf08700ce3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Probes for HOME
• Version Model Number: TP022
• Company DUNS: 651755092
• Company Name: ICARE FINLAND OY
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430033850947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163343

FDA Product Code

• HKX: Tonometer, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-12
• Device Publish Date: 2020-04-15

On-Brand Devices [Probes for HOME]

• 06430033850626: Single unit blister package
• 16430033850623: Sales package 50pcs
• 06430033850947: Sales package 20pcs of TP022 probes