SCLERAL DEPRESSOR T10-3825

GUDID 00192896012219

SCLERAL DEPRESSOR WITH CLIP DOUBLE ENDED TIPS TITANIUM

SONTEC INSTRUMENTS, INC.

Scleral marker, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable Orbital depressor, reusable

• Primary Device ID: 00192896012219
• NIH Device Record Key: ce214a01-bd20-4e50-9e75-f5ad2ecca30e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCLERAL DEPRESSOR
• Version Model Number: T10-3825
• Catalog Number: T10-3825
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896012219 [Primary]

FDA Product Code

• HMQ: Marker, sclera
• HNX: Depressor, Orbital

Sterilization

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

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896012219]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-27
• Device Publish Date: 2018-09-18

On-Brand Devices [SCLERAL DEPRESSOR]

• 00192896012219: SCLERAL DEPRESSOR WITH CLIP DOUBLE ENDED TIPS TITANIUM
• 00192896012196: SCLERAL DEPRESSOR WITH CLIP DOUBLE ENDED TIP
• 00192896102859: Scleral Depressor With Clip Double-Ended Titanium