PASCAL 311.701.201

GUDID 07640167751174

SensorCaps-240

SMT Swiss Microtechnology AG

Ophthalmic tonometer, battery-operated

• Primary Device ID: 07640167751174
• NIH Device Record Key: bf6d53bc-7026-428f-b571-00dc0987f577
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASCAL
• Version Model Number: Sensorcaps
• Catalog Number: 311.701.201
• Company DUNS: 481980881
• Company Name: SMT Swiss Microtechnology AG
• Device Count: 240
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640167751174 [Primary]
GS1	07640167751181 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032967

FDA Product Code

• HKY: Tonometer, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15