Schioetz Tonometer - Allen Wrench Modification 13110

GUDID B091131100

Manual tonometer used to gauge internal pressure within the eye. An allen wrench can be used to adjust weight settings.

Gulden Ophthalmics Inc.

Ophthalmic tonometer, manual

• Primary Device ID: B091131100
• NIH Device Record Key: b686c1c6-4d60-4f46-a285-058627c3b629
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Schioetz Tonometer - Allen Wrench Modification
• Version Model Number: 13110
• Catalog Number: 13110
• 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	B091131100 [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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