SUCTION HANDLE 18-8028

GUDID 00192896019621

SUCTION CUP HANDLE SILICONE BLUE

SONTEC INSTRUMENTS, INC.

Radiation/mechanical corneal shield, reusable

• Primary Device ID: 00192896019621
• NIH Device Record Key: 0f9a30b4-2cca-438a-870d-ab190700dd51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUCTION HANDLE
• Version Model Number: 18-8028
• Catalog Number: 18-8028
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896019621 [Primary]

FDA Product Code

• MDM: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• MOE: Collagen Corneal Shield

Sterilization

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

[00192896019621]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-10-03

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