EYE SHIELD 18-8022B

GUDID 00192896019607

EYE SHIELD WITH HANDLE BLUE ELECTRO COATED

SONTEC INSTRUMENTS, INC.

Radiation/mechanical corneal shield, reusable

• Primary Device ID: 00192896019607
• NIH Device Record Key: 343f11dc-4e6d-417c-9e8d-b75896b56d06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EYE SHIELD
• Version Model Number: 18-8022B
• Catalog Number: 18-8022B
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896019607 [Primary]

FDA Product Code

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

Sterilization

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

[00192896019607]

Dry Heat Sterilization;Moist Heat or Steam 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

On-Brand Devices [EYE SHIELD]

• 00192896075184: EYE SHIELD SMOOTH SURFACE BLUE ELECTRO COATED
• 00192896075177: EYE SHIELD PAIR SMOOTH SURFACE STAINLESS STEEL
• 00192896075160: EYE SHIELD WITH HANDLE STAINLESS STEEL
• 00192896019614: EYE SHIELD SMOOTH SURFACE STAINLESS STEEL
• 00192896019607: EYE SHIELD WITH HANDLE BLUE ELECTRO COATED
• 00192896019591: EYE SHIELD WITH HANDLE STAINLESS STEEL
• 00192896103399: Cox II Eye Shield With Suction Cup Large Stainless Steel
• 00192896103382: Cox II Eye Shield With Suction Cup Medium Stainless Steel