CARTER SPHERE INTRODUCER 17-1000

GUDID 00192896019317

CARTER SPHERE INTRODUCER

SONTEC INSTRUMENTS, INC.

Orbital sphere implant introducer

• Primary Device ID: 00192896019317
• NIH Device Record Key: 93087d0e-975b-4a3b-82ef-be6a6f561d9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARTER SPHERE INTRODUCER
• Version Model Number: 17-1000
• Catalog Number: 17-1000
• 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
• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896019317 [Primary]

FDA Product Code

• HNC: Specula, ophthalmic
• HNP: Introducer, Sphere

Sterilization

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

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896019317]

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: 2018-10-15
• Device Publish Date: 2018-09-14

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