HIGH RESOLUTION LED LOUPE J-008.31.346

GUDID 00192896071681

HIGH RESOLUTION LED LOUPE WITH I-VIEW & S-GUARD

SONTEC INSTRUMENTS, INC.

Loupe

• Primary Device ID: 00192896071681
• NIH Device Record Key: fa38f0a2-2c66-4a5e-99ad-9cc4eb20e60d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIGH RESOLUTION LED LOUPE
• Version Model Number: J-008.31.346
• Catalog Number: J-008.31.346
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896071681 [Primary]

FDA Product Code

• FSP: LOUPE, DIAGNOSTIC/SURGICAL

Sterilization

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

[00192896071681]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-09-12

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