HEINE - EN 100 TRANSFORMER ONLY X-095.12.110

GUDID 00192896009608

HEINE - EN 100 TRANSFORMER ONLY

SONTEC INSTRUMENTS, INC.

Indirect binocular ophthalmoscope, battery-powered

• Primary Device ID: 00192896009608
• NIH Device Record Key: e5830c61-d8db-4ffa-8457-5428adeb96dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEINE - EN 100 TRANSFORMER ONLY
• Version Model Number: X-095.12.110
• Catalog Number: X-095.12.110
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896009608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142486

FDA Product Code

• HLJ: Ophthalmoscope, Battery-Powered

Sterilization

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

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896009608]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-17
• Device Publish Date: 2018-08-15

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