Schioetz Tonometer 13107

GUDID B091131070

Manual Tonometer is used to gauge the internal pressure of the eye using weights and a tonometer tip.

Gulden Ophthalmics Inc.

Ophthalmic tonometer, manual

• Primary Device ID: B091131070
• NIH Device Record Key: 658bba3d-2491-4925-a5a9-8dbfaff1b885
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Schioetz Tonometer
• Version Model Number: 13107
• Catalog Number: 13107
• Company DUNS: 002373249
• Company Name: Gulden Ophthalmics Inc.
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com
• Phone: 1-800-659-2250
• Email: admin@guldenophthalmics.com

Device Dimensions

• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch
• Width: 2 Inch
• Length: 5.25 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B091131070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945541

FDA Product Code

• HKY: Tonometer, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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